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)

Status: Recruiting
Location: See all (41) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Arizona
Pulmonary Associates, PA ( Site 1008)
RECRUITING
Phoenix
California
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
ACTIVE_NOT_RECRUITING
Santa Barbara
Stanford University Medical Center ( Site 1024)
RECRUITING
Stanford
Colorado
South Denver Cardiology Associates ( Site 1091)
ACTIVE_NOT_RECRUITING
Littleton
Florida
AdventHealth Orlando ( Site 1058)
RECRUITING
Orlando
Georgia
The Emory Clinic ( Site 1030)
RECRUITING
Atlanta
Kentucky
Norton Pulmonary Specialists ( Site 1066)
ACTIVE_NOT_RECRUITING
Louisville
Nebraska
University Of Nebraska Medical Center ( Site 1053)
ACTIVE_NOT_RECRUITING
Omaha
New York
Weill Cornell Medical Center ( Site 1046)
RECRUITING
New York
Ohio
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
RECRUITING
Cincinnati
Pennsylvania
Allegheny General Hospital ( Site 1088)
RECRUITING
Pittsburgh
Lankenau Medical Center ( Site 1089)
ACTIVE_NOT_RECRUITING
Wynnewood
South Carolina
Medical University of South Carolina ( Site 1003)
RECRUITING
Charleston
Tennessee
Statcare Pulmonary Consultants ( Site 1031)
RECRUITING
Knoxville
Utah
Intermountain Medical Center ( Site 1079)
RECRUITING
Murray
Virginia
Inova Heart and Vascular Institute ( Site 1078)
RECRUITING
Falls Church
Pulmonary Associates of Richmond - West Broad Street ( Site 1069)
RECRUITING
Richmond
Other Locations
Belgium
Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)
ACTIVE_NOT_RECRUITING
Brussels
Canada
Hamilton Health Sciences Hamilton General Hospital ( Site 0004)
RECRUITING
Hamilton
France
Centre Hopitalier Universitaire d'Angers ( Site 0204)
ACTIVE_NOT_RECRUITING
Angers
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)
ACTIVE_NOT_RECRUITING
Le Kremlin-bicêtre
Hopital Arnaud de Villeneuve ( Site 0200)
ACTIVE_NOT_RECRUITING
Montpellier
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206)
ACTIVE_NOT_RECRUITING
Nice
CHU de Rouen ( Site 0203)
ACTIVE_NOT_RECRUITING
Rouen
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205)
ACTIVE_NOT_RECRUITING
Saint-herblain
Germany
Thoraxklinik-Heidelberg gGmbH ( Site 0309)
ACTIVE_NOT_RECRUITING
Heidelberg
Israel
Rambam Health Care Campus ( Site 0403)
RECRUITING
Haifa
Edith Wolfson Medical Center ( Site 0404)
ACTIVE_NOT_RECRUITING
Holon
Hadassah Medical Center ( Site 0402)
RECRUITING
Jerusalem
Meir Medical Center ( Site 0401)
RECRUITING
Kfar Saba
ZIV Medical Center ( Site 0400)
ACTIVE_NOT_RECRUITING
Safed
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)
RECRUITING
Bergamo
Fondazione IRCCS Policlinico San Matteo ( Site 0501)
RECRUITING
Pavia
AOU Policlinico Umberto I ( Site 0500)
RECRUITING
Roma
Spain
Hospital Clinic I Provincial de Barcelona ( Site 0701)
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitario 12 de Octubre ( Site 0702)
ACTIVE_NOT_RECRUITING
Madrid
Hospital Costa del Sol ( Site 0704)
RECRUITING
Marbella
Hospital Universitario Virgen Macarena ( Site 0705)
RECRUITING
Seville
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)
ACTIVE_NOT_RECRUITING
Toledo
Sweden
Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)
RECRUITING
Gothenburg
United Kingdom
Hammersmith Hospital-Department of Cardiology ( Site 0900)
ACTIVE_NOT_RECRUITING
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 130
Treatments
Experimental: Sotatercept 0.3 mg/kg
Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 168 weeks or until discontinuation.
Experimental: Sotatercept 0.7 mg/kg
Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 168 weeks or until discontinuation.
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov