RecruitingPhase 2NCT06814145

Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)

A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

130 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

Hypertension, Pulmonary

Summary

Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF). Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time. The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term follow-up study for people who completed a previous clinical trial (called CADENCE) of a drug called sotatercept (brand name Winrevair) for pulmonary arterial hypertension — a serious condition where blood pressure in the lungs is dangerously high, making the heart work harder. The goal is to continue monitoring participants over time to track the drug's ongoing safety and effectiveness. **You may be eligible if...** - You completed the previous CADENCE study (MK-7962-007) without stopping treatment early - Your doctor has confirmed it is safe for you to continue in this extension study **You may NOT be eligible if...** - You have certain types of pulmonary hypertension not covered in this study (WHO Groups 1, 3, 4, or 5) - Your treatment was interrupted during the CADENCE study - You are pregnant or breastfeeding - You have severe liver disease or cirrhosis - You need more than one heart valve repair or replacement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSotatercept

subcutaneous injection

Locations(56)

Pulmonary Associates, PA ( Site 1008)

Phoenix, Arizona, United States

Jeffrey S. Sager, MD Medical Corporation ( Site 1060)

Santa Barbara, California, United States

Stanford University Medical Center ( Site 1024)

Stanford, California, United States

South Denver Cardiology Associates ( Site 1091)

Littleton, Colorado, United States

Yale New Haven Hospital ( Site 1093)

New Haven, Connecticut, United States

AdventHealth Orlando ( Site 1058)

Orlando, Florida, United States

The Emory Clinic ( Site 1030)

Atlanta, Georgia, United States

Norton Pulmonary Specialists ( Site 1066)

Louisville, Kentucky, United States

University Of Nebraska Medical Center ( Site 1053)

Omaha, Nebraska, United States

Weill Cornell Medical Center ( Site 1046)

New York, New York, United States

Duke University Medical Center ( Site 1026)

Durham, North Carolina, United States

The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation. ( Site 1065)

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center ( Site 1032)

Columbus, Ohio, United States

Allegheny General Hospital ( Site 1088)

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center ( Site 1089)

Wynnewood, Pennsylvania, United States

Rhode Island Hospital ( Site 1039)

Providence, Rhode Island, United States

Medical University of South Carolina ( Site 1003)

Charleston, South Carolina, United States

Statcare Pulmonary Consultants ( Site 1031)

Knoxville, Tennessee, United States

Intermountain Medical Center ( Site 1079)

Murray, Utah, United States

Inova Fairfax Medical Campus ( Site 1078)

Falls Church, Virginia, United States

Pulmonary Associates of Richmond - West Broad Street ( Site 1069)

Richmond, Virginia, United States

Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)

Brussels, Bruxelles-Capitale, Region de, Belgium

Hamilton Health Sciences Hamilton General Hospital ( Site 0004)

Hamilton, Ontario, Canada

Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206)

Nice, Alpes-Maritimes, France

Hopital Arnaud de Villeneuve ( Site 0200)

Montpellier, Herault, France

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205)

Saint-Herblain, Loire-Atlantique, France

Centre Hopitalier Universitaire d'Angers ( Site 0204)

Angers, Maine-et-Loire, France

CHU de Rouen ( Site 0203)

Rouen, Seine-Maritime, France

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)

Le Kremlin-Bicêtre, Val-de-Marne, France

Thoraxklinik-Heidelberg gGmbH ( Site 0309)

Heidelberg, Baden-Wurttemberg, Germany

Krankenhaus Neuwittelsbach ( Site 0310)

München, Bavaria, Germany

UKGM Gießen/Marburg ( Site 0312)

Giessen, Hesse, Germany

Universitaetsklinikum Koeln ( Site 0311)

Cologne, North Rhine-Westphalia, Germany

Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315)

Mainz, Rhineland-Palatinate, Germany

Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301)

Dresden, Saxony, Germany

DRK Kliniken Berlin Westend ( Site 0307)

Berlin, Germany

Rambam Health Care Campus ( Site 0403)

Haifa, Israel

Edith Wolfson Medical Center ( Site 0404)

Holon, Israel

Hadassah Medical Center ( Site 0402)

Jerusalem, Israel

Meir Medical Center ( Site 0401)

Kfar Saba, Israel

ZIV Medical Center ( Site 0400)

Safed, Israel

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)

Bergamo, Lombardy, Italy

Fondazione IRCCS Policlinico San Matteo ( Site 0501)

Pavia, Italy

AOU Policlinico Umberto I ( Site 0500)

Roma, Italy

Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505)

Monterrey, Nuevo León, Mexico

Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddzial Kliniczny Chorob Serca i Naczyn z Podod ( Site 0600)

Krakow, Lesser Poland Voivodeship, Poland

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601)

Lublin, Lublin Voivodeship, Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603)

Bialystok, Podlaskie Voivodeship, Poland

Hospital Costa del Sol ( Site 0704)

Marbella, Malaga, Spain

Hospital Clinic I Provincial de Barcelona ( Site 0701)

Barcelona, Spain

Hospital Universitario 12 de Octubre ( Site 0702)

Madrid, Spain

Hospital Universitario Virgen Macarena ( Site 0705)

Seville, Spain

HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)

Toledo, Spain

Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)

Gothenburg, Västra Götaland County, Sweden

Hammersmith Hospital-Department of Cardiology ( Site 0900)

London, London, City of, United Kingdom

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