New drug aims to unload the heart in lung hypertension
NCT ID NCT06658522
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether the drug sotatercept can improve right heart function in people with pulmonary arterial hypertension (PAH). PAH causes high blood pressure in the lungs, straining the right side of the heart. Sotatercept targets the underlying blood vessel changes, not just widening vessels. Twenty adults will receive injections every three weeks for 24 weeks, and doctors will measure heart function with imaging and catheterization. The goal is to see if the drug makes the heart work more efficiently.
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 drug injected under the skin)
- What this could lead to
- If it works, this could show that sotatercept improves heart efficiency and delays right heart failure in people with pulmonary arterial hypertension.
- What could go wrong
- This is a small, early-phase study with only 20 participants and no placebo group, so results may not apply broadly. The drug may not improve heart function as hoped.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Adult patients between 18-70 years of age 2. Able to provide signed informed consent 3. WHO FC II to IV 4. NTproBNP \> 300 ng/L 5. PAH etiology belonging to one of the following groups (Nice classification): * Idiopathic PAH * Heritable PAH 6. Hemodynamic diagnosis of PAH confirmed by RHC during screening showing: * mPAP \> 20 mmHg * Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg * PVR ≥ 4WU (320 dyn.sec.cm-5) 7. For patients treated with oral diuretics, treatment dose must have been stable at least 1 month prior to RHC during the screening period 8. All patients are on stable background therapy at least 3 months prior to RHC during the screening period 9. Women of childbearing potential must have a negative pregnancy test at screening and agree to use reliable methods of contraception 10. Males must agree to use a condom during sexual contact with a pregnant female or female of childbearing potential while participating in the study. Males should refrain from donating blood or sperm for the duration for the study and for 16 weeks after last dose of sotatercept Exclusion Criteria: 1. Any contraindication to treatment with sotatercept 2. Body weight \< 40 kg 3. Body mass index (BMI) \> 35kg/m2 4. Pregnancy, breastfeeding, or intention to become pregnant during the study 5. Recently started (\< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program 6. Known concomitant life-threatening disease with a life expectancy \< 12 months 7. Any condition likely to affect protocol or treatment compliance 8. Hospitalization for PAH within 3 months prior to informed consent signature 9. Left atrial volume per body surface area ≥ 43mL/m2 by echocardiography or CMR 10. Valvular disease grade 2 or higher 11. History of pulmonary embolism or deep vein thrombosis 12. Documented moderate to severe chronic obstructive pulmonary disease 13. Documented moderate to severe restrictive lung disease 14. Historical evidence of significant coronary artery disease 15. Diabetes mellitus 16. Active cancer 17. Systolic blood pressure \< 90 mmHg 18. Need for dialysis 19. Responders to acute vasoreactivity testing based on medical history 20. Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation) 21. Claustrophobia 22. Permanent cardiac pacemaker, automatic internal cardioverter 23. Metallic implant (e.g. defibrillator, neurostimulator, hearing aid, infusion device) 24. Atrial fibrillation, multiple premature ventricular or atrial contractions , or any other condition that would interfere with proper cardiac gating during CMR. 25. History of major bleeding 26. Hemoglobin above ULN for age and gender
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Amsterdam UMC, location VUMC
RECRUITINGAmsterdam, North Holland, 1081HV, Netherlands
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