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Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
NCT06814145 · Merck Sharp & Dohme LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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)
About this study
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 criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
\- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment \[EOT\] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
* Has had a study intervention interruption
* Is pregnant or breastfeeding
* Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
* Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
* Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)
* Anticipated or undergone heart transplant or ventricular assist device implantation
* Has had prior exposure to luspatercept
Study design
Enrollment target: 130 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-04-16
Estimated completion: 2029-03-30
Last updated: 2026-04-06
Interventions
Biological: Sotatercept
Primary outcomes
- • Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 187 weeks)
- • Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 168 weeks)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (56)
Pulmonary Associates, PA ( Site 1008)Active Not Recruiting
Phoenix, Arizona, United States
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)Active Not Recruiting
Santa Barbara, California, United States
Stanford University Medical Center ( Site 1024)Active Not Recruiting
Stanford, California, United States
South Denver Cardiology Associates ( Site 1091)Active Not Recruiting
Littleton, Colorado, United States
Yale New Haven Hospital ( Site 1093)Active Not Recruiting
New Haven, Connecticut, United States
AdventHealth Orlando ( Site 1058)Active Not Recruiting
Orlando, Florida, United States
The Emory Clinic ( Site 1030)Recruiting
Atlanta, Georgia, United States
Norton Pulmonary Specialists ( Site 1066)Active Not Recruiting
Louisville, Kentucky, United States
University Of Nebraska Medical Center ( Site 1053)Active Not Recruiting
Omaha, Nebraska, United States
Weill Cornell Medical Center ( Site 1046)Active Not Recruiting
New York, New York, United States
Duke University Medical Center ( Site 1026)Recruiting
Durham, North Carolina, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)Active Not Recruiting
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation. ( Site 1065)Active Not Recruiting
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center ( Site 1032)Active Not Recruiting
Columbus, Ohio, United States
Allegheny General Hospital ( Site 1088)Active Not Recruiting
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center ( Site 1089)Active Not Recruiting
Wynnewood, Pennsylvania, United States
Rhode Island Hospital ( Site 1039)Active Not Recruiting
Providence, Rhode Island, United States
Medical University of South Carolina ( Site 1003)Active Not Recruiting
Charleston, South Carolina, United States
Statcare Pulmonary Consultants ( Site 1031)Active Not Recruiting
Knoxville, Tennessee, United States
Intermountain Medical Center ( Site 1079)Active Not Recruiting
Murray, Utah, United States
Inova Fairfax Medical Campus ( Site 1078)Active Not Recruiting
Falls Church, Virginia, United States
Pulmonary Associates of Richmond - West Broad Street ( Site 1069)Active Not Recruiting
Richmond, Virginia, United States
Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)Active Not Recruiting
Brussels, Bruxelles-Capitale, Region de, Belgium
Hamilton Health Sciences Hamilton General Hospital ( Site 0004)Active Not Recruiting
Hamilton, Ontario, Canada
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206)Active Not Recruiting
Nice, Alpes-Maritimes, France
Hopital Arnaud de Villeneuve ( Site 0200)Active Not Recruiting
Montpellier, Herault, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205)Active Not Recruiting
Saint-Herblain, Loire-Atlantique, France
Centre Hopitalier Universitaire d'Angers ( Site 0204)Active Not Recruiting
Angers, Maine-et-Loire, France
CHU de Rouen ( Site 0203)Active Not Recruiting
Rouen, Seine-Maritime, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)Active Not Recruiting
Le Kremlin-Bicêtre, Val-de-Marne, France
Thoraxklinik-Heidelberg gGmbH ( Site 0309)Active Not Recruiting
Heidelberg, Baden-Wurttemberg, Germany
Krankenhaus Neuwittelsbach ( Site 0310)Recruiting
München, Bavaria, Germany
UKGM Gießen/Marburg ( Site 0312)Active Not Recruiting
Giessen, Hesse, Germany
Universitaetsklinikum Koeln ( Site 0311)Active Not Recruiting
Cologne, North Rhine-Westphalia, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315)Active Not Recruiting
Mainz, Rhineland-Palatinate, Germany
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301)Recruiting
Dresden, Saxony, Germany
DRK Kliniken Berlin Westend ( Site 0307)Recruiting
Berlin, Germany
Rambam Health Care Campus ( Site 0403)Active Not Recruiting
Haifa, Israel
Edith Wolfson Medical Center ( Site 0404)Active Not Recruiting
Holon, Israel
Hadassah Medical Center ( Site 0402)Active Not Recruiting
Jerusalem, Israel
Meir Medical Center ( Site 0401)Active Not Recruiting
Kfar Saba, Israel
ZIV Medical Center ( Site 0400)Active Not Recruiting
Safed, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)Active Not Recruiting
Bergamo, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo ( Site 0501)Active Not Recruiting
Pavia, Italy
AOU Policlinico Umberto I ( Site 0500)Active Not Recruiting
Roma, Italy
Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505)Recruiting
Monterrey, Nuevo León, Mexico
Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddzial Kliniczny Chorob Serca i Naczyn z Podod ( Site 0600)Active Not Recruiting
Krakow, Lesser Poland Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601)Active Not Recruiting
Lublin, Lublin Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603)Active Not Recruiting
Bialystok, Podlaskie Voivodeship, Poland
Hospital Costa del Sol ( Site 0704)Active Not Recruiting
Marbella, Malaga, Spain
Hospital Clinic I Provincial de Barcelona ( Site 0701)Active Not Recruiting
Barcelona, Spain
Hospital Universitario 12 de Octubre ( Site 0702)Active Not Recruiting
Madrid, Spain
Hospital Universitario Virgen Macarena ( Site 0705)Active Not Recruiting
Seville, Spain
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)Active Not Recruiting
Toledo, Spain
Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)Active Not Recruiting
Gothenburg, Västra Götaland County, Sweden
Hammersmith Hospital-Department of Cardiology ( Site 0900)Active Not Recruiting
London, London, City of, United Kingdom