The PROSERA Study

Working to make a difference to the lives of people with pulmonary arterial hypertension

Explore Study Locations

Welcome to the PROSERA Study

We hope you find this information helpful. If participating in the study may be of interest to you, click here to view the summary. You can also print it and take it to discuss with your doctor or specialist.

About The Study

What is the PROSERA Study?

The PROSERA Study is a Phase 3 clinical research study designed to help researchers understand whether an inhaled investigational product called seralutinib* may be an effective and safe future treatment for adults with pulmonary arterial hypertension.

Understanding pulmonary arterial hypertension

Pulmonary arterial hypertension is a rare, progressive disease that occurs when there is an overgrowth of cells in the small blood vessels that supply the lungs. This overgrowth causes the arteries to become narrower and stiffer, disrupting the flow of blood through the heart and lungs.

There are three connected pathways that contribute to pulmonary arterial hypertension and its progression: inflammation, proliferation and fibrosis. Inflammation occurs when an injury in the body activates the immune system to start the healing process. In pulmonary arterial hypertension, this inflammatory response is abnormally activated, and causes cells in the blood vessel walls of the lung to multiply too much, known as proliferation. This proliferation of cells ultimately changes tissue flexibility because the blood vessel walls thicken, causing the small arteries in the lungs to become narrow and constricted. As the disease progresses, the walls of these blood vessels can scar and become rigid, known as fibrosis. Symptoms of pulmonary arterial hypertension include shortness of breath, chest pain, fatigue, and/or lack of energy.

Watch Professor Luke Howard (Consultant Pulmonologist) discussing pulmonary arterial hypertension in more detail

Investigational Study Drugs

The PROSERA Study is a randomized double-blind clinical trial, which means each participant will be randomly allocated to receive either seralutinib or placebo. In order to test one against the other, neither the participant nor the study doctor will know which treatment they will receive. This is standard practice, it helps prevent bias when doctors evaluate the participant outcomes, improving the reliability of the study results.

Seralutinib
With the PROSERA Study, we hope to understand the effect of seralutinib on specific pathways in the body that lead to the inflammation, proliferation and fibrosis associated with pulmonary arterial hypertension. Currently there is no treatment available that targets these specific pathways collectively.

This study is designed to see if, by blocking these pathways, seralutinib can prevent or reverse the effects of pulmonary arterial hypertension when added to currently approved therapies. It is produced as a fine dry powder to be inhaled using a small hand-held device. During the study, we also hope to gain an understanding of the safety and tolerability of seralutinib.

Placebo
A placebo looks like the active drug, but does not contain any active medication. Using a placebo allows the research team to compare the effectiveness and safety of seralutinib in a standardized manner.

What's involved?

At all stages of the study, you will undergo some tests and procedures. These tests will track your health and progress, and may include the following:

Medical history and physical examinations

Blood and urine tests

6-minute walk tests (6MWT)

You will be asked to walk as far as you can in six minutes

Echo and electrocardiograms

Tests that provide images of your heart and check its rate and rhythm

Lung function tests

You will be asked to take deep breaths and blow into a machine to measure how well your lungs are working

Right heart catheterization

A procedure performed to measure the blood pressure inside your lungs and the blood flow and function in the right side of your heart. Right heart catheterization will be required at screening, unless you have had one within the last 6 months

*Seralutinib has not been approved for commercial use by the US FDA or any other regulatory agency.

Could I Be Eligible?

Please answer the following questions to see whether you might be eligible to take part in the PROSERA Study.

After completing all questions, please click SUBMIT. It’s important to note that clicking “SUBMIT” does not mean that you agree to participate in the study.

Question 1

Are you an adult aged 18 to 75 years?

Question 2

Have you been diagnosed with pulmonary arterial hypertension?

Question 3

Are you being treated with at least one pulmonary arterial hypertension disease-specific medication?

Question 4

Do you have a body mass index (BMI) between 17 and 40 kg/m2?

If you are unsure, click here to help calculate your body mass index

Question 5

Could you be pregnant?

Questionnaire Submitted

Thank you for submitting your questionnaire.

×

Based on your provided answers, you may be eligible for taking part in the PROSERA Study. Please consult your doctor if you are interested in taking part in the PROSERA Study. Click here to view the summary which you can download or print, and take to discuss with your doctor or specialist.

×

Based on your responses, it appears that you do not currently meet the eligibility criteria for the study. If there are changes in your answers to any of these questions in the future, please check again to re-evaluate your eligibility. If you have a confirmed diagnosis of pulmonary arterial hypertension and are still interested in taking part in the PROSERA Study, please contact your doctor or specialist who may be able to advise you further. We appreciate your interest in the PROSERA Study. Thank you.

What next?

If you think this clinical research study might be for you, and you are interested in taking part, download this summary or email it to your doctor or specialist to discuss it further.

The PROSERA Study Timeline

The PROSERA Study will be conducted for a minimum of 24 weeks and involve screening, treatment, and follow-up appointments.

The study has 4 parts

1

Screening

Up to 4 weeks

Circle

Screening

Up to 4 weeks

Pre-screening

  • You will be required to stay on your current pulmonary arterial hypertension medications at the same dose for 12 weeks prior to screening

Confirming your eligibility to take part in the study

  • Screening period of up to 4 weeks
  • Full medical check-up, including discussing medical history
  • Blood and urine sample tests
  • Tests and checks on your heart and lungs (e.g., echo and electrocardiogram, 6MWT, and lung function test)
  • Right heart catheterization will be required at screening, unless you have had one within the last 6 months

2

Treatment Period

Minimum 24 weeks

Circle

Treatment Period

Minimum 24 weeks

Study period

  • You will be randomized after screening to receive seralutinib or placebo capsules twice a day, inhaled with a dry powder inhaler
  • You will be required to attend check-up appointments to monitor your disease and assess the safety of the study drug throughout the study
  • Neither you nor the study doctor will know which study drug you will be taking
  • The study will last up to 48 weeks, or until the last patient in the PROSERA Study has completed 24 weeks of treatment

3a

Follow-up

4 weeks after final dose

Circle

Follow-up

4 weeks after final dose

After the final dose

  • If you decide not to take part in the PROSERA-EXT Study (open-label extension), 4 weeks after your last dose, you will attend a follow-up appointment
  • The follow-up allows the study doctor to monitor your health after you have stopped receiving treatment
  • Tests may include full medical check-up and blood and urine sample tests

3b

PROSERA-EXT

Long-term study

Circle

PROSERA-EXT

Long-term study

Open-Label Extension Study

  • Once you complete the main study, you will have the opportunity to join an open-label extension (OLE) study, called PROSERA-EXT
  • You will have the chance to continue taking seralutinib, or switch to seralutinib if you were taking placebo

4

End of Study

Circle

End of Study

Results

  • Upon study completion and finalization of the study report, results will be made available via https://euclinicaltrials.eu and http://www.ClinicalTrials.gov
  • Once the study is over for all participants, your study doctor will be able to let you know if you received seralutinib or placebo

4

End of Study

Circle

End of Study

Results

  • Upon study completion and finalization of the study report, results will be made available via https://euclinicaltrials.eu and http://www.ClinicalTrials.gov
  • Once the study is over for all participants, your study doctor will be able to let you know if you received seralutinib or placebo

Study Locations

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Type in your city or ZIP code and your closest study sites will appear as blue pinpoints on the map.

Keio University Hospital

Distance

Address:

35 Shinanomachi, Shinjuku City, Tokyo 160-0016, Japan

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Kyushu University Hospital

Distance

Address:

3 Chome-1-1 Maidashi, Higashi Ward, Fukuoka, 812-8582, Japan

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Fundacion Neumologica Colombiana

Distance

Address:

Carrera 13 B Numero 161-85, Piso 3. Usaquen, Bogota, Bogota 110131

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Hospital Madre Teresa

Distance

Address:

Avenida Raja Gabaglia 1002, Portaria 01. Pharmacy - subsolo, Belo Horizonte, Minas Gerais 10130-100

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Kurume University Hospital

Distance

Address:

Kurume University Hospital, Pharmaceutical Department, ６７ Asahi-machi, Kurume-shi, Fukuoka 830-0011

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Hospital Universitario San Ignacio

Distance

Address:

Carrera 7 No. 40-62, Oficina 726. Investigaciones, Bogota, Bogota 110231

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Fundacion Neumologica Colombiana

Distance

Address:

Carrera 13 B Numero 161-85, Piso 3. Usaquen, Bogota, Bogota 110131

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LMU Klinikum Großhadern, Med. V

Distance

Address:

Marchininistr. 15, München, 81377

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Fundacion Clinica Shaio

Distance

Address:

Diagonal 115A 70 C 75, Bogota, Colombia 111121

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Hospital São Paulo

Distance

Address:

Rua Napoleão De Barros 715, Vila Clementino, Sao Paulo, Sao Paulo 04024-002

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Instituto do Coração - HCFMUSP

Distance

Address:

Avenida Doutor Enéas Carvalho De Aguiar 155 , 1 Andar. Cerqueira César, Sao Paulo, Sao Paulo 05403-000

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Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

Distance

Address:

Avenida Ipiranga 6690, Centro de Pesquisa Clinica. 4º Andar, Porto Alegre, Rio Grande do Sul 90610-000

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Hospital Dia do Pulmão

Distance

Address:

Rua Engenheiro Paul Werner 1141, Itoupava Seca, Blumenau, Santa Catarina 89030-101

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Nagoya University Hospital

Distance

Address:

Nagoya University Hospital, Center for Advanced Medicine and Clinical Research, 65 Tsurumai-cho, Showa-ku, Nagoya-Shi, Aichi 466-8560

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The University of Tokyo Hospital

Distance

Address:

The University of Tokyo Hospital, Clinical Research Promotion Center, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655

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Kyorin University Hospital

Distance

Address:

Kyorin University Hospital, Clinical Trial Management Office, 6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611

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Evangelismos General Hospital of Athens

Distance

Address:

Ypsilantou 45-47, , 3rd Floor Pateras Building, 1st Intensive Care Unit Department, Athens, 10676, Athina, Attiki 106 76

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Mater Misericordiae University Hospital (MMUH)

Distance

Address:

Eccles Street, Phibsborough, Dublin 7, Dublin, Ireland D07 R2WY

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AKH Wien - Medizinische Universität Wien

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Address:

Währinger Gürtel 18-20, Innere Medizin II – Kardiologie, Ebene 6, 6.L2.07, Vienna, Vienna 1090

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Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)

Distance

Address:

Strada di Fiume 447, Polo Cardiologico - S.C. Cardiologia, 1st Floor, Trieste, Friuli-Venezia Giulia 34149

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Royal Free Hospital

Distance

Address:

Rheumatology Office, Pond Street, Lower Ground, Room 301, London, N/A NW3 2QG

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Royal Hallamshire Hospital

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Address:

Glossop Road, Clinical Research Facility (STH22777), Sheffield, S10 2JF

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Freeman Hospital

Distance

Address:

Freeman Road, High Heaton, Newcastle Upon Tyne, Tyne and Wear NE7 7DN

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University Health Network, Toronto General Hospital

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Address:

200 Elizabeth Street, 12EN-240, Toronto, Ontario M5G 2C4

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Peter Lougheed Centre

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Address:

Peter Lougheed Centre, 3500 26 Ave NE, Respiratory Research Rm 1100, Calgary, Alberta T1Y 6J4

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Brigham and Womens Hospital

Distance

Address:

15 Francis St. , Carrie Hall CA-310, Boston, Massachusetts 02115

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ABRAF - Brazilian Pulmonary Hypertension and Related Diseases Association

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Address:

R. Dr. Virgílio de Carvalho Pinto, 445 - Pinheiros, São Paulo - SP, 05415-030, Brazil

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Peter Lougheed Centre

Distance

Address:

3500 26 Ave NE, Rm 1100, Calgary, Alberta T1Y 6J4

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University of Ottawa Heart Institute

Distance

Address:

40 Ruskin St, Pulmonary Hypertension Dept, Ottawa, Ontario K1Y 4W7

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NHO Okayama Medical Center

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Address:

NHO Okayama Medical Center, Clinical Study Management, Main Building 3F, 1711-1 Tamasu, Kita-ku, Okayama-shi, Okayama 701-1192

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Penn Pulmonary Vascular Disease Program

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Address:

3737 Market St, Philadelphia, Pennsylvania 19104

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The Wesley Research Institute

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Address:

451 Coronation Drive, Level 8, East Wing, Auchenflower, QLD 4066

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Klinikum der Universität zu Köln, Herzzentrum, PAH-Ambulanz

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Address:

Kerpener Str. 62, 50937 Köln, Germany

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King Fahad Medical City

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Address:

Makkah Al Mukarramah Branch Road, As, Sulaymaniyah, Riyadh, 12231

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Rhode Island Hospital

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Address:

593 Eddy St, Providence, RI 02903, United States

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King Faisal Specialist Hospital and Research Center

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Address:

Al Takhassusi Street, Riyadh, 11211

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UT Health Science Center, San Antonio

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Address:

7703 Floyd Curl Dr, San Antonio, TX 78229, United States

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LHSC

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Address:

800 Commissioners Rd E Rm E1633, London, ON N6A 5W9, Canada

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Aarhus Universitetshospital

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Address:

Palle Juul-Jensens Blvd. 99, 8200 Aarhus, Denmark

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Instituto Cardiovascular de Buenos Aires

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Address:

Av. del Libertador 6302, C1428 Cdad. Autónoma de Buenos Aires, Argentina

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Mediprax Centrum

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Address:

Strada Petru Maior 6-8, Cluj-Napoca 400002, Romania

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University of Cincinnati

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Address:

200 Albert Sabin Way, Suite 1001, Cincinnati, Ohio 45267

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Tufts Medical Center

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Address:

800 Washington St, Boston, MA 02111, United States

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INSTITUTUL INIMII

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Address:

Calea Moților 19-21, Cluj-Napoca 400001, Romania

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AHEPA University General Hospital of Thessaloniki

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Address:

Kiriakidi 1, Thessaloniki 546 36, Greece

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Instituto Medico Rio Cuarto

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Address:

Hipólito Yrigoyen 1020, X5800 Río Cuarto, Córdoba, Argentina

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Attikon University General Hospital

Distance

Address:

Rimini 1, Chaidari 124 62, Greece

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Emergency Institute of Cardiovascular Diseases Prof. Dr. C. C. Iliescu

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Address:

258 Fundeni Road, Bucharest, Bucharest 22328

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Hospital Universitario 12 de Octubre

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Address:

Av. de Córdoba, s/n, Usera, 28041 Madrid, Spain

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Institute of Cardiovascular Diseases (Dedinje)

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Address:

Heroja Milana Tepića 1, Beograd, Serbia

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Clinic of Cardiology, University Clinical Center of Serbia

Distance

Address:

Dr Koste Todorovića 8, Beograd, Serbia

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Irmandade Da Santa Casa de Misericordia de Porto Alegre

Distance

Address:

Rua Professor Annes Dias, 295 - 2° andar - Centro Histórico, Porto Alegre - RS, 90020-090, Brazil

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National Cerebral and Cardiovascular Center

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Address:

6-1 Kishibeshinmachi, Suita, Osaka 564-8565, Japan

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Hospital Universitario de Toledo

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Address:

Av. del Río Guadiana, 45007 Toledo, Spain

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Hospital Universitari i Politecnic La Fe de Valencia

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Address:

Avinguda de Fernando Abril Martorell, 106, Quatre Carreres, 46026 València, Spain

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Royal Papworth Hospital NHS Foundation Trust

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Address:

Papworth Rd, Trumpington, Cambridge CB2 0AY

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Krankenhaus Neuwittelsbach

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Address:

Renatastraße 71A, 80639 München, Germany

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Universitätsmedizin Greifswald

Distance

Address:

Ferdinand-Sauerbruch-Straße , Klinik und Poliklinik für Innere Medizin B, Greifswald, Greifswald 17475

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Universitätsklinikum des Saarlandes

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Address:

Kirrberger Str. 100, 66424 Homburg, Germany

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Hospital Universitario Dr. Jose Eleuterio González

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Address:

Av. Dr. José Eleuterio González S/N, Mitras Centro, 64460 Monterrey, N.L., Mexico

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Unidad de Investigación Clínica En Medicina SC

Distance

Address:

De La Clínica 2520, Sertoma, 64718 Monterrey, N.L., Mexico

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Instituto Nacional de Cardiologia Dr. Ignacio Chavez

Distance

Address:

Belisario Domínguez Secc 16, 14080 Mexico City, CDMX, Mexico

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Ochsner Medical Center

Distance

Address:

1514 Jefferson Hwy, Jefferson, LA 70121, United States

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The Medical Research Group, Inc. 

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Address:

7151 N Cedar Ave, Fresno, CA 93720, USA

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UAB Medicine

Distance

Address:

20th St Community Health Services Bldg, 930 20th St S, Birmingham, AL 35294, United States

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Baylor Scott & White Medical Center - Plano

Distance

Address:

1100 Allied Dr, Plano, TX 75093, United States

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Winchester Center for Lung Disease

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Address:

789 Howard Avenue Fitkin, Building 209, New Haven, CT 06519, United States

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Baylor University Medical Center

Distance

Address:

3410 Worth St, Dallas, TX 75246, USA

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University Of Iowa Hospitals And Clinics

Distance

Address:

Iowa City, IA 52242, United States

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Temple University Hospital

Distance

Address:

3509 N Broad St, Philadelphia, PA 19140, United States

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Mayo Clinic Jacksonville

Distance

Address:

4500 San Pablo Rd S, Jacksonville, FL 32224, United States

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University of Maryland Medical Center

Distance

Address:

110 South Paca St, Baltimore, MD 21201, USA

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Enroll SpA - PPDS

Distance

Address:

Dr. Manuel Barros Borgoño 160, 7500587 Providencia, Región Metropolitana, Chile

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Instituto de Investigaciones Clinicas Quilmes

Distance

Address:

Sarmiento 315, B1878 Quilmes, Provincia de Buenos Aires, Argentina

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Royal Hobart Hospital

Distance

Address:

Cardiology Department, Level 2 48 Liverpool Street, Hobart, Tasmania 7000

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Vseobecna Fakultni Nemocnice V Praze

Distance

Address:

U Nemocnice 2, Ii. Interni Klinika Kardiologie A Angiologie Vfn A 1.lf Uk, Praha, Praha, hlavní mesto 128 08

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Rigshospitalet

Distance

Address:

Inge Lehmanns Vej 7, Clinic for heartdiseases , 2142, Copenhagen East, Capital 2100

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Fondazione IRCCS Policlinico San Matteo

Distance

Address:

Viale Golgi, 19, UOC Cardiology,DEA building,third floor,tower B , Pavia, 27100

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Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi-Via Massarenti

Distance

Address:

Via Massarenti 9, Cardiologic department, 21 building, Bologna, Emilia-Romagna 40138

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Azienda Ospedaliera Monaldi

Distance

Address:

Via Leonardo Bianchi, 80131 Napoli NA, Italy

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Royal Brompton Hospital

Distance

Address:

Sydney Street, Pulmonary Hypertension Service, London, London SW3 6NP

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Golden Jubilee National Hospital

Distance

Address:

Agamemnon Street, R&D, Glasgow, West Dunbartonshire G81 4DY

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Universitätsklinikum Halle (Saale)

Distance

Address:

Ernst-Grube-Str. 40, Halle , Sachsen-Anhalt 06120

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Universitätsklinikum Dresden

Distance

Address:

Fetscherstr. 74, Dresden, Dresden 01307

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Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg

Distance

Address:

Röntgenstraße 1, Zentrum für pulmonale Hypertonie, Heidelberg, Heidelberg 69126

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DRK Kliniken Berlin Westend

Distance

Address:

Spandauer Damm 130, Kardiologie/Hochhaus 6.Etage , Berlin, Berlin 14050

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Universitätsklinikum Hamburg-Eppendorf

Distance

Address:

Martinistr. 52, Zentrum für Onkologie, Studienzentrale Pneumologie, Hamburg, Hamburg 20246

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Universitätsklinikum Giessen und Marburg GmbH

Distance

Address:

Klinikstr. 33, Gießen, Hessen 35392

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Medizinische Hochschule Hannover

Distance

Address:

Carl-Neuberg Straße 1, Klinik für Pneumologie und Infektiologie, Hannover, Hannover 30625

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Intermountain Medical Center

Distance

Address:

5121 Cottonwood St, Murray, UT 84107, United States

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University of Southern California-Keck School of Medicine

Distance

Address:

1640 Marengo St Ste 700, Los Angeles, California 90033-1057

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University of Missouri Health Care

Distance

Address:

One Hospital Drive, Medicine- Pulmonary Environment, CE432, Columbia, Missouri 65212

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University of Illinois at Chicago

Distance

Address:

909 S Wolcott Ave, Chicago, IL 60612, United States

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Massachusetts General Hospital

Distance

Address:

55 Fruit St, Boston, MA 02114, United States

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VA Greater Los Angeles Healthcare System - Cardiology

Distance

Address:

11301 Wilshire Blvd, Bldg. 500, Cardiology Section 111-E Room 4438, Los Angeles, California 90073

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Stanford University Medical Center

Distance

Address:

300 Pasteur Dr, Stanford, California 94305-2200

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The George Washington University Medical Faculty Associates

Distance

Address:

2150 Pennsylvania Ave NW , Suite 4-412, Washington, District of Columbia 20037

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Emory Clinic

Distance

Address:

1365 Clifton Rd NE, Atlanta, Georgia 30322-1013

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Medical College of Wisconsin

Distance

Address:

8701 W Watertown Plank Rd, Medicine- Pulmonary and Critical Care, 8th Floor of Hub, Milwaukee, Wisconsin 53226

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Washington University School of Medicine - Center for Advanced Medicine

Distance

Address:

660 S Euclid Ave, MSC 8052-43-14, Saint Louis, Missouri 63110

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UPMC Presbyterian Hospital

Distance

Address:

200 Lothrop St, Pittsburgh, PA 15213, United States

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University of Colorado - Health Sciences Center

Distance

Address:

12605 East 16th Avenue, Pulmonary Hypertension Clinic, Aurora, Colorado 80045

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University of North Carolina at Chapel Hill

Distance

Address:

UNC at Chapel Hill , 130 Mason Farm Road, CB 7020, Chapel Hill, North Carolina 27599

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Inova Fairfax Hospital

Distance

Address:

3300 Gallows Rd, Falls Church, VA 22042, United States

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Cleveland Clinic

Distance

Address:

9500 Euclid Ave, Cleveland, OH 44106, United States

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National University of Singapore

Distance

Address:

5 Lower Kent Ridge Road, Singapore, Singapore 119082

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National Heart Centre

Distance

Address:

5 Hospital Drive, Singapore, Singapore 169609

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Pontificia Universidad Catolica de Chile

Distance

Address:

Portugal 61, 8320000 Santiago, Región Metropolitana, Chile

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Hospital Privado Centro Médico de Córdoba S.A

Distance

Address:

Cordoba, Provincia de Cordoba X5016KEH

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Nepean Hospital

Distance

Address:

Nepean Hospital, Cardiac Services Level 5, Building C, NSW, 2747

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Onassis Cardiac Surgery Center

Distance

Address:

Leof. Andrea Siggrou 356, Kallithea 176 74, Greece

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Institut Klinicke A Experimentalni Mediciny

Distance

Address:

Vídeňská 1958, 140 21 Praha 4, Czechia

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Ordensklinikum Linz Elisabethinen

Distance

Address:

Fadingerstraße 1, 4020 Linz, Austria

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VU University Medical Center

Distance

Address:

De Boelelaan 1117, 1081 HV Amsterdam, Netherlands

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Erasmus University Medical Center

Distance

Address:

Dr. Molewaterplein 40, Rotterdam, Zuid-Holland 3015 GD

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Hospital Universitario Vall d'Hebron

Distance

Address:

Vall d'Hebron 119-129, Barcelona, Barcelona 08035

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IRCCS Opsedale Policlinico San Martino

Distance

Address:

Largo Rosanna Benzi 10, Genova, Liguria 16132

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Klinikum Würzburg Mitte gGmbH

Distance

Address:

Salvatorstraße 7, 97074 Würzburg, Germany

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Northwestern University

Distance

Address:

240 E Huron St, Chicago, IL 60611, USA

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University of Minnesota

Distance

Address:

420 Delaware Street MMC 508 Minneapolis, MN 55455, Minnesota, Minnesota

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Norton Pulmonary Specialists

Distance

Address:

100 W Market St Ste 2, Louisville, Kentucky 40202-1332

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Duke University Medical Center

Distance

Address:

330 Trent Dr, Durham, NC 27710, USA

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Medical University of South Carolina

Distance

Address:

96 Jonathan Lucas St, Charleston, SC 29425, USA

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St. Luke's Health - Baylor St. Luke's Medical Center - Houston, TX

Distance

Address:

7200 Cambridge St, Houston, TX 77030, USA

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Cardiologia Palermo

Distance

Address:

Comunidad Autonoma de Buenos Aires, Ciudad Autonoma de Buenos Aires C1425BNG

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Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina

Distance

Address:

Borowa 14/18, 05-400 Otwock, Poland

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UZ Leuven Campus Gasthuisberg

Distance

Address:

Herestraat 49, 3000 Leuven, Belgium

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Complejo Asistencial Universitario de Salamanca – H. Clinico

Distance

Address:

P.º de San Vicente, 58, 37007 Salamanca, Spain

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Hospital Universitario Marques de Valdecilla

Distance

Address:

Av. de Valdecilla, s/n, 39008 Santander, Cantabria, Spain

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Puerta de Hierro Majadahonda University Hospital

Distance

Address:

C. Joaquín Rodrigo, 1, 28222 Majadahonda, Madrid, Spain

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Hammersmith Hospital

Distance

Address:

72 Du Cane Rd, London W12 0HS

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University of Connecticut

Distance

Address:

263 Farmington Ave, Farmington, CT 06032, USA

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Aurora Saint Luke's Medical Center

Distance

Address:

2900 W Oklahoma Ave, Milwaukee, WI 53215, United States

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University of Nebraska Medical Center

Distance

Address:

42nd and, Emile St, Omaha, NE 68198, United States

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UC Davis Health Medical Center

Distance

Address:

Pulmonary, Critical Care and Sleep Medicine Research , Sacramento, California 95817

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University of Rochester

Distance

Address:

601 Elmwood Ave, Rochester, NY 14642, USA

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Allegheny General Hospital

Distance

Address:

320 E North Ave, Pittsburgh, PA 15212, United States

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Centro Hospitalar de Santo António

Distance

Address:

Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

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Centro Hospitalar de Santo António

Distance

Address:

Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

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Centro Hospitalar de Santo António

Distance

Address:

Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

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Centro Hospitalar de Santo António

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Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

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Centro Hospitalar de Santo António

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Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

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Centro Hospitalar de Santo António

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Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

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Hospital Universitario Son Espases

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Carretera de Valldemossa, 79, Nord, 07120 Palma, Illes Balears, Spain

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Northside Hospital

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1000 Johnson Ferry Rd NE, Atlanta, GA 30342, USA

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NYU Langone Health

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462 1st Ave., New York, NY 10016, USA

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Sanatorio Parque S.A.

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Address:

Blvd. Oroño 860, S2000 Rosario, Santa Fe, Argentina

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Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil

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1 Pl. de l'Hôpital, 67000 Strasbourg, France

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Hospital Provincial Dr. Jose Maria Cullen

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Av. Gdor. Freyre 2138, S3000EOM S3000EOM, Santa Fe, Argentina

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INTEGRIS Family Care Central

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3400 Northwest Expy Building C, Suite 500, Oklahoma City, OK 73112, United States

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Mayo Clinic

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200 1st St SW, Rochester, MN 55905, United States

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Instituto de Cardiologia de Corrientes Juana Francisca Cabral

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Bolívar 1334, W3400CDS Corrientes, Argentina

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Tel Aviv Sourasky Medical Center

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Weizmann St 6, Tel Aviv-Yafo, Israel

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Meir MC

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Tchernichovsky St 59, Kefar Sava, 4428164, Israel

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The Chaim Sheba Medical Center

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Derech Sheba 2, Ramat Gan, Israel

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Hadassah University Hospital Ein-Karem

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Kalman Ya'akov Man St, Jerusalem, Israel

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Lady Davis Carmel Medical Center

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Mikhal St 7, Haifa, 3436212, Israel

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Rabin Medical Center

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ז'בוטינסקי 39, Petah Tikva, 4941492, Israel

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Seoul National University Hospital

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101 Daehak-ro, Jongno-gu, Seoul, South Korea

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Samsung Medical Center

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81 Irwon-ro, Gangnam-gu, Seoul, South Korea

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Gachon University Gil Medical Center

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21 Namdong-daero 774beon-gil, Guwol-dong, Namdong-gu, Incheon, South Korea

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Severance Hospital Yonsei University Health System

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50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, South Korea

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Asan Medical Center

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88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea

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The Catholic University of Korea, Seoul St. Mary's Hospital

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222 Banpo-daero, Seocho-gu, Seoul, South Korea

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Macquarie University Hospital

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Level 3, 75 Talavera Rd, Macquarie Park NSW 2113, Australia

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St Vincents Hospital Melbourne

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41 Victoria Parade, Fitzroy VIC 3065, Australia

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Hospital of Lithuanian University of Health Sciences Kaunas Clinics

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Eivenių g. 2, 50161 Kaunas, Lithuania

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P.Stradins Clinical University Hospital

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Pilsoņu iela 13, Zemgales priekšpilsēta, Rīga, LV-1002, Latvia

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Piedmont Healthcare

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275 Collier Rd NW unit 450, Atlanta, GA 30309, United States

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Centro Hospital Universitário de Coimbra, EPE

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Praceta Professor Mota Pinto, 3004-561 Coimbra, Portugal

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Centro Hospitalar de Vila Nova de Gaia e Espinho

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R. Conceição Fernandes S/N, 4434-502 Vila Nova de Gaia, Portugal

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Centro Hospitalar de Lisboa Norte E.P.E – Hospital Pulido Valente

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Alameda das Linhas de Torres 117, 1769-001 Lisboa, Portugal

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Targu-Mures Emergency Clinical County Hospital

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Strada Gheorghe Marinescu 50, Târgu Mureș 540136, Romania

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Krakowski Szpital Specjalistyczny im. Sw.Jana Pawla II

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Prądnicka 80, 31-202 Kraków, Poland

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Hôpital Erasme (Cliniques Universitaires de Bruxelles)

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Rte de Lennik 808, 1070 Bruxelles, Belgium

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Hospital Universitario Virgen del Rocio

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Av. Manuel Siurot, S/n, 41013 Sevilla, Spain

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Hospital Costa del Sol

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A-7, Km 187, 29603 Marbella, Málaga, Spain

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Hospital Clinic de Barcelona

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Carrer de Villarroel, 170, 08036 Barcelona, Barcelona, Spain

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Azienda Ospedaliero Universitaria Policlinico Umberto I

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Viale del Policlinico, 155, 00161 Roma RM, Italy

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CHU de LILLE-Institut Cœur Poumon

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Address:

Bd du Professeur Jules Leclercq, 59000 Lille, France

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CHU de Nancy-Hopital Brabois Adulte

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4 Av. de Bourgogne, 54500 Vandœuvre-lès-Nancy, France

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CHRU de Poitiers La Miletrie

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2 Rue de la Milétrie, 86000 Poitiers, France

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Centre Hospitalier Universitaire de Bicêtre

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78 Rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France

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CHU Montpellier- Hôpital Arnaud de VIlleneuve

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371 Avenue du Doyen Gaston Giraud, Montpellier, Hérault, France

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Hôpital Pasteur

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Hôpital Pasteur, 30 Voie Romaine, Nice, France

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Allianze Pulmonary Research, LLC

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Address:

Maramar Plaza Bldg, Suite 200, Guaynabo, San Juan 00968

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University of California Irvine

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Address:

333 City Blvd W Ste 400, Orange, California 92868-2994, United States

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Oregon Health and Science University

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3181 Southwest Sam Jackson Park Road, Portland, Oregon 97239, United States

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Wexner Medical Center at The Ohio State University

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410 W 10th Ave, Columbus, Ohio 43210-1240, United States

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Jeffrey S. Sager, MD Medical Corporation

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2428 Castillo St. Ste D, Santa Barbara, California 93105-5311, United States

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University of New Mexico Health Sciences Center

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915 Camino de Salud, NE, Albuquerque, NM 87131, United States

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Houston Methodist Hospital

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6550 Fannin St, Houston, TX 77030, United States

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University of Michigan

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South State Street, Ann Arbor, MI 48109, United States

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Pulmonary Associates of Richmond, Inc.

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Address:

Richmond, Virginia 23230, United States

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University of Kansas Medical Center

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Kansas City, Kansas 66160, United States

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Discover Your Local Patient Support Groups

Use your mouse to move the map and discover your local support group by clicking on the red pin

Above Country Support Groups

Alliance for Pulmonary Hypertension

www.allianceforpulmonaryhypertension.com

PHA Europe

www.phaeurope.org

Sociedad Latina Hipertension Pulmonar

www.sociedadlatinahp.org

Global Allergy & Airways Patient Platform

www.gaapp.org

Frequently Asked Questions

About the PROSERA Study

What is a clinical research study?

Clinical trials are a type of research that investigate new treatments and evaluate their effects on human health outcomes.

What is 'informed consent'?

The informed consent process provides you with relevant information about the clinical research study, so you can decide if you want to participate. It involves:

  • Reporting all the relevant study details
  • Summarizing why the research is being conducted
  • Voluntary decision-making

The informed consent process gives you the opportunity to be an informed participant in your healthcare decisions. You choose to enter a clinical research study freely (voluntarily), based on receiving complete information on what it means to take part. You must read and sign the informed consent form to be able to join the study.

Have any studies been conducted on seralutinib previously, and what were the results?

Seralutinib has previously been studied in the Phase 2 TORREY Study. More details of the TORREY Study can be found here: https://www.gossamerbio.com/pipeline/pipeline-overview/

For how long will I take part in this study?

After a 4-week screening period to assess your eligibility to participate, the study will last up to 48 weeks, or until the last participant has completed 24 weeks of treatment, with a follow-up visit 4 weeks after your final dose (10-15 visits in total). All participants who complete the study will be invited to continue/switch to seralutinib in the PROSERA-EXT Study.

Can I still take my current pulmonary arterial hypertension medication during the study?

Yes, you can take up to three medicines to help manage your pulmonary arterial hypertension, in addition to the study treatment.

Will I be compensated for participating in the study?

Yes. The study medicine, device, tests and procedures will be provided to you at no cost, and you may be reimbursed for study-related time and expenses.

What side effects might I experience?

The most common side effect reported from participants in the Phase 2 TORREY Study was a mild-to-moderate cough. This can be associated with taking the medication through dry powder inhalers. If you experience any side effects while taking the study medication, please report these to the study doctor as soon as possible.

What is a 'placebo'?

A treatment that looks like the active drug, but does not contain any active medication.

Will there be an option to transfer to the study drug if on the placebo?

At the end of the treatment period, you will have the chance to continue taking seralutinib – or switch to it if you were on placebo – in the PROSERA-EXT Study.

Privacy, Withdrawing, Costs, and Permission

What happens to my personal information if I participate?

Basic personal information may be recorded in your study medical records, including your name, contact details, gender, height, weight and racial origin, as well as information about your medical history, and clinical data collected during your participation in the study.

Your confidentiality will be respected, and no information that discloses your identity will be published without your consent unless required by law.

Can I withdraw from the clinical trial early?

You can change your mind and withdraw your consent at any time, and for any reason, without your usual medical treatment being affected.

If you have any further questions about your eligibility, or about the PROSERA Study, please contact your doctor or specialist.

Share this study

Copy and paste the link below to tell a friend or family member about the PROSERA Study

ClinicalTrials.gov euclinicaltrials.eu