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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

Full criteria on ClinicalTrials.gov

Sites (57)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)
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BrusselsBelgiumUnknown status
Hamilton Health Sciences Hamilton General Hospital ( Site 0004)
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HamiltonCanadaUnknown status
DRK Kliniken Berlin Westend ( Site 0307)
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BerlinGermanyUnknown status
Universitaetsklinikum Koeln ( Site 0311)
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CologneGermanyUnknown status
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301)
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DresdenGermanyUnknown status
UKGM Gießen/Marburg ( Site 0312)
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GiessenGermanyUnknown status
Thoraxklinik-Heidelberg gGmbH ( Site 0309)
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HeidelbergGermanyUnknown status
Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315)
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MainzGermanyUnknown status
Krankenhaus Neuwittelsbach ( Site 0310)
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MünchenGermanyUnknown status
Hospital Clinic I Provincial de Barcelona ( Site 0701)
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BarcelonaSpainUnknown status
Hospital Universitario 12 de Octubre ( Site 0702)
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MadridSpainUnknown status
Hospital Costa del Sol ( Site 0704)
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MarbellaSpainUnknown status
Hospital Universitario Virgen Macarena ( Site 0705)
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SevilleSpainUnknown status
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)
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ToledoSpainUnknown status
Centre Hopitalier Universitaire d'Angers ( Site 0204)
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AngersFranceUnknown status
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)
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Le Kremlin-BicêtreFranceUnknown status
Hopital Arnaud de Villeneuve ( Site 0200)
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MontpellierFranceUnknown status
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206)
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NiceFranceUnknown status
CHU de Rouen ( Site 0203)
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RouenFranceUnknown status
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205)
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Saint-HerblainFranceUnknown status
Hammersmith Hospital-Department of Cardiology ( Site 0900)
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LondonUnited KingdomUnknown status
Rambam Health Care Campus ( Site 0403)
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HaifaIsraelUnknown status
Edith Wolfson Medical Center ( Site 0404)
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HolonIsraelUnknown status
Hadassah Medical Center ( Site 0402)
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JerusalemIsraelUnknown status
Meir Medical Center ( Site 0401)
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Kfar SabaIsraelUnknown status
ZIV Medical Center ( Site 0400)
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SafedIsraelUnknown status
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)
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BergamoItalyUnknown status
Fondazione IRCCS Policlinico San Matteo ( Site 0501)
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PaviaItalyUnknown status
AOU Policlinico Umberto I ( Site 0500)
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RomaItalyUnknown status
Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505)
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MonterreyMexicoUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603)
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BialystokPolandUnknown status
Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddzial Kliniczny Chorob Serca i Naczyn z Podod ( Site 0600)
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KrakowPolandUnknown status
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601)
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LublinPolandUnknown status
Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)
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GothenburgSwedenUnknown status
The Emory Clinic ( Site 1030)
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AtlantaUnited StatesUnknown status
Medical University of South Carolina ( Site 1003)
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CharlestonUnited StatesUnknown status
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
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CincinnatiUnited StatesUnknown status
The Cleveland Clinic Foundation. ( Site 1065)
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ClevelandUnited StatesUnknown status
The Ohio State University Wexner Medical Center ( Site 1032)
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ColumbusUnited StatesUnknown status
Duke University Medical Center ( Site 1026)
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DurhamUnited StatesUnknown status
Inova Fairfax Medical Campus ( Site 1078)
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Falls ChurchUnited StatesUnknown status
Statcare Pulmonary Consultants ( Site 1031)
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KnoxvilleUnited StatesUnknown status
Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004)
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La JollaUnited StatesUnknown status
South Denver Cardiology Associates ( Site 1091)
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LittletonUnited StatesUnknown status
Norton Pulmonary Specialists ( Site 1066)
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LouisvilleUnited StatesUnknown status
Intermountain Medical Center ( Site 1079)
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MurrayUnited StatesUnknown status
Yale New Haven Hospital ( Site 1093)
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New HavenUnited StatesUnknown status
Weill Cornell Medical Center ( Site 1046)
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New YorkUnited StatesUnknown status
University Of Nebraska Medical Center ( Site 1053)
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OmahaUnited StatesUnknown status
AdventHealth Orlando ( Site 1058)
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OrlandoUnited StatesUnknown status
Pulmonary Associates, PA ( Site 1008)
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PhoenixUnited StatesUnknown status
Allegheny General Hospital ( Site 1088)
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PittsburghUnited StatesUnknown status
Rhode Island Hospital ( Site 1039)
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ProvidenceUnited StatesUnknown status
Pulmonary Associates of Richmond - West Broad Street ( Site 1069)
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RichmondUnited StatesUnknown status
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
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Santa BarbaraUnited StatesUnknown status
Stanford University Medical Center ( Site 1024)
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StanfordUnited StatesUnknown status
Lankenau Medical Center ( Site 1089)
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WynnewoodUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.