Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heart-Lung hope: new drug sotatercept tested for tough hypertension

NCT ID NCT06814145

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This study looks at the long-term safety of a drug called sotatercept for people with a specific type of pulmonary hypertension caused by heart failure with preserved ejection fraction. About 130 people who completed a prior study will receive sotatercept injections and be monitored for side effects and how well they tolerate the drug. The main goal is to see if the drug is safe over a longer period, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sotatercept (a biologic drug given as a shot under the skin)
What this could lead to
If it works, this could point toward a treatment that helps people with this specific type of pulmonary hypertension breathe easier and be more active.
What could go wrong
This is a small, early-phase extension study focused on safety, not proof of benefit. The drug may not improve symptoms or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 440 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Aug 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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) 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 and has an ongoing SAE that occurred during parent study and is suspected to be related to study intervention * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Heart failure with preserved ejection fraction are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

diastolic heart failure pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension, pulmonary

Contacts and locations

Locations

  • AOU Policlinico Umberto I ( Site 0500)

    Roma, 00161, Italy

  • AdventHealth Orlando ( Site 1058)

    Orlando, Florida, 32803, United States

  • Allegheny General Hospital ( Site 1088)

    Pittsburgh, Pennsylvania, 15212-4737, United States

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)

    Bergamo, Lombardy, 24127, Italy

  • CHU de Rouen ( Site 0203)

    Rouen, Seine-Maritime, 76031, France

  • Centre Hopitalier Universitaire d'Angers ( Site 0204)

    Angers, Maine-et-Loire, 49100, France

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

    Nice, Alpes-Maritimes, 06000, France

  • DRK Kliniken Berlin Westend ( Site 0307)

    Berlin, 14050, Germany

  • Duke University Medical Center ( Site 1026)

    Durham, North Carolina, 27710-4000, United States

  • Edith Wolfson Medical Center ( Site 0404)

    Holon, 5810001, Israel

  • Fondazione IRCCS Policlinico San Matteo ( Site 0501)

    Pavia, 27100, Italy

  • HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)

    Toledo, 45007, Spain

  • Hadassah Medical Center ( Site 0402)

    Jerusalem, 9112001, Israel

  • Hamilton Health Sciences Hamilton General Hospital ( Site 0004)

    Hamilton, Ontario, L8L 2X2, Canada

  • Hammersmith Hospital-Department of Cardiology ( Site 0900)

    London, London, City of, W12 OHS, United Kingdom

  • Hopital Arnaud de Villeneuve ( Site 0200)

    Montpellier, Herault, 34295, France

  • Hospital Clinic I Provincial de Barcelona ( Site 0701)

    Barcelona, 08036, Spain

  • Hospital Costa del Sol ( Site 0704)

    Marbella, Malaga, 29603, Spain

  • Hospital Universitario 12 de Octubre ( Site 0702)

    Madrid, 28041, Spain

  • Hospital Universitario Virgen Macarena ( Site 0705)

    Seville, 41009, Spain

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

    Saint-Herblain, Loire-Atlantique, 44800, France

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)

    Le Kremlin-Bicêtre, Val-de-Marne, 94270, France

  • Inova Fairfax Medical Campus ( Site 1078)

    Falls Church, Virginia, 22042, United States

  • Intermountain Medical Center ( Site 1079)

    Murray, Utah, 84107, United States

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

    Santa Barbara, California, 93105, United States

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

    Krakow, Lesser Poland Voivodeship, 31-202, Poland

  • Krankenhaus Neuwittelsbach ( Site 0310)

    München, Bavaria, 80639, Germany

  • Lankenau Medical Center ( Site 1089)

    Wynnewood, Pennsylvania, 19096, United States

  • Medical University of South Carolina ( Site 1003)

    Charleston, South Carolina, 29425, United States

  • Meir Medical Center ( Site 0401)

    Kfar Saba, 4428164, Israel

  • Norton Pulmonary Specialists ( Site 1066)

    Louisville, Kentucky, 40202, United States

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

    Richmond, Virginia, 23230, United States

  • Pulmonary Associates, PA ( Site 1008)

    Phoenix, Arizona, 85032, United States

  • Rambam Health Care Campus ( Site 0403)

    Haifa, 3109601, Israel

  • Rhode Island Hospital ( Site 1039)

    Providence, Rhode Island, 02903, United States

  • Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)

    Gothenburg, Västra Götaland County, 413 46, Sweden

  • Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004)

    La Jolla, California, 92037, United States

  • South Denver Cardiology Associates ( Site 1091)

    Littleton, Colorado, 80120, United States

  • Stanford University Medical Center ( Site 1024)

    Stanford, California, 94305, United States

  • Statcare Pulmonary Consultants ( Site 1031)

    Knoxville, Tennessee, 37919, United States

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

    Cincinnati, Ohio, 45219, United States

  • The Cleveland Clinic Foundation. ( Site 1065)

    Cleveland, Ohio, 44195, United States

  • The Emory Clinic ( Site 1030)

    Atlanta, Georgia, 30322, United States

  • The Ohio State University Wexner Medical Center ( Site 1032)

    Columbus, Ohio, 43210, United States

  • Thoraxklinik-Heidelberg gGmbH ( Site 0309)

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • UKGM Gießen/Marburg ( Site 0312)

    Giessen, Hesse, 35392, Germany

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

    Monterrey, Nuevo León, 64718, Mexico

  • Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301)

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Koeln ( Site 0311)

    Cologne, North Rhine-Westphalia, 50937, Germany

  • University Of Nebraska Medical Center ( Site 1053)

    Omaha, Nebraska, 68198, United States

  • Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315)

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)

    Brussels, Bruxelles-Capitale, Region de, 1070, Belgium

  • Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603)

    Bialystok, Podlaskie Voivodeship, 15-276, Poland

  • Weill Cornell Medical Center ( Site 1046)

    New York, New York, 10065, United States

  • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601)

    Lublin, Lublin Voivodeship, 20-718, Poland

  • Yale New Haven Hospital ( Site 1093)

    New Haven, Connecticut, 06520, United States

  • ZIV Medical Center ( Site 0400)

    Safed, 1311001, Israel

More trials for these conditions

Other studies related to the condition(s) this trial covers.