Can a new drug keep hearts and lungs stronger in a Tough-to-Treat form of pulmonary hypertension?
NCT ID NCT07839585
First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time
Summary
Researchers are testing whether sotatercept helps adults with combined postcapillary and precapillary pulmonary hypertension (CpcPH) linked to heart failure with preserved ejection fraction (HFpEF). The trial compares sotatercept injections to placebo in about 350 participants. The main goal is to see if sotatercept lengthens the time before the condition worsens, such as needing hospitalization or experiencing a decline in exercise capacity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sotatercept, an injected biologic drug
- What this could lead to
- If it works, sotatercept could become a new treatment option for people with this type of pulmonary hypertension and heart failure, helping them live longer without their condition worsening.
- What could go wrong
- This is a phase 3 trial, so it is still testing whether the drug works. Sotatercept may not improve outcomes, and it can cause side effects such as changes in blood counts or bleeding. The results may not apply to all patients with this condition.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 352 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 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: The main inclusion criteria include but are not limited to the following: * Has clinical diagnosis of HF with preserved ejection fraction on optimized guideline-directed medical therapy * Has CpcPH confirmed by right-heart catheterization * Has NYHA FC II or III Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a diagnosis of PH in World Health Organization Group 1, 3, 4, or 5 * Has CV comorbidities: * History of surgical or transcatheter correction of mitral or aortic stenosis or regurgitation within 12 months before Screening * More than one valve replacement or repair (mechanical or bioprosthetic), or anticipated valve replacement or repair during the study * History of serious, life-threatening, or hemodynamically significant arrhythmia, long corrected QT interval syndrome, or Brugada syndrome * History of hypertrophic cardiomyopathy, infiltrative cardiomyopathy (including, but not limited to, cardiac amyloidosis), dilated cardiomyopathy, arrhythmogenic ventricular cardiomyopathy, or restrictive cardiomyopathy * History or evidence of chronic liver disease * Has a current diagnosis of end-stage renal disease * History of organ transplantation (except corneal transplant) or bone marrow transplantation ≤5 years before Screening or has a life expectancy of \<12 months * History of malignancy ≤5 years before Screening, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or ≤2 squamous cell carcinomas of the skin * Has any noncardiopulmonary condition or acute/chronic impairment(s) (other than dyspnea) that limits their ability to perform the 6-minute walk test * Has moderate or severe obstructive sleep apnea * Has a body mass index ≥50 kg/m\^2 * Has been treated with any approved pulmonary arterial hypertension-specific medications within 30 days of Randomization * Has background medication with the following agents: sodium-glucose cotransporter-2 inhibitor, renin-angiotensin-aldosterone system inhibitors, mineralocorticoid receptor antagonists, diuretics, and beta-blockers, that is not a stable dose for ≥30 days before Randomization
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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