Can a new drug keep hearts and lungs stronger in a Tough-to-Treat form of pulmonary hypertension?

NCT ID NCT07839585

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 352 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

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 to 85 years

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: * 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

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  1. The official record

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