NCT06814145Active, not recruitingPhase 2
Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
A Phase 2, Multicenter, Open-label Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) With Heart Failure With Preserved Ejection Fraction (HFpEF)
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- First submitted
- 3 Feb 2025
- Start date
- 16 Apr 2025
- Primary completion date
- 10 Aug 2035
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT06814145
- EU CT number
- 2024-515773-99-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 440
- From 16 Apr 2025 to the primary completion date, 10 Aug 2035
- 57 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has had prior exposure to luspatercept
Other illness
- 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 chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
- 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
Other
- The main exclusion criteria include but are not limited to the following:
- Has had a study intervention interruption and has an ongoing SAE that occurred during parent study and is suspected to be related to study intervention
- Is pregnant or breastfeeding
- Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
Who the study is looking for
- The main inclusion criteria include but are not limited to the following:
- \- Completed sotatercept parent study (MK-7962-007\[CADENCE\] \[Visit 9 and EOT visit\] or MK-7962-041 \[P041\] \[EOT Visit\]) without discontinuing study intervention and is able to safely enroll into MK-7962-023 (HARMONIZE)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (57)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Université Libre de Bruxelles - Hôpital Erasme ( Site 0100) Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Hamilton Health Sciences Hamilton General Hospital ( Site 0004) Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| DRK Kliniken Berlin Westend ( Site 0307) Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitaetsklinikum Koeln ( Site 0311) Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301) Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| UKGM Gießen/Marburg ( Site 0312) Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
| Thoraxklinik-Heidelberg gGmbH ( Site 0309) Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315) Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Krankenhaus Neuwittelsbach ( Site 0310) Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Hospital Clinic I Provincial de Barcelona ( Site 0701) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario 12 de Octubre ( Site 0702) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Costa del Sol ( Site 0704) Coordinator of this site? Confirm its status | Marbella | Spain | Unknown status |
| Hospital Universitario Virgen Macarena ( Site 0705) Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703) Coordinator of this site? Confirm its status | Toledo | Spain | Unknown status |
| Centre Hopitalier Universitaire d'Angers ( Site 0204) Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202) Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| Hopital Arnaud de Villeneuve ( Site 0200) Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206) Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| CHU de Rouen ( Site 0203) Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205) Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| Hammersmith Hospital-Department of Cardiology ( Site 0900) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Rambam Health Care Campus ( Site 0403) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Edith Wolfson Medical Center ( Site 0404) Coordinator of this site? Confirm its status | Holon | Israel | Unknown status |
| Hadassah Medical Center ( Site 0402) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Meir Medical Center ( Site 0401) Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| ZIV Medical Center ( Site 0400) Coordinator of this site? Confirm its status | Safed | Israel | Unknown status |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502) Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Fondazione IRCCS Policlinico San Matteo ( Site 0501) Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| AOU Policlinico Umberto I ( Site 0500) Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505) Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603) Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddzial Kliniczny Chorob Serca i Naczyn z Podod ( Site 0600) Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601) Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800) Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| The Emory Clinic ( Site 1030) Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Medical University of South Carolina ( Site 1003) Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| The Cleveland Clinic Foundation. ( Site 1065) Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The Ohio State University Wexner Medical Center ( Site 1032) Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Duke University Medical Center ( Site 1026) Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Inova Fairfax Medical Campus ( Site 1078) Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
| Statcare Pulmonary Consultants ( Site 1031) Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004) Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| South Denver Cardiology Associates ( Site 1091) Coordinator of this site? Confirm its status | Littleton | United States | Unknown status |
| Norton Pulmonary Specialists ( Site 1066) Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Intermountain Medical Center ( Site 1079) Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
| Yale New Haven Hospital ( Site 1093) Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Weill Cornell Medical Center ( Site 1046) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University Of Nebraska Medical Center ( Site 1053) Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| AdventHealth Orlando ( Site 1058) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Pulmonary Associates, PA ( Site 1008) Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Allegheny General Hospital ( Site 1088) Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Rhode Island Hospital ( Site 1039) Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Pulmonary Associates of Richmond - West Broad Street ( Site 1069) Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Jeffrey S. Sager, MD Medical Corporation ( Site 1060) Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
| Stanford University Medical Center ( Site 1024) Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Lankenau Medical Center ( Site 1089) Coordinator of this site? Confirm its status | Wynnewood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.