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New drug combo could help heart defect patients with severe lung pressure

NCT ID NCT07356778

Disease control Sponsor: Kazuya Hosokawa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the drug sotatercept to usual treatments can improve exercise ability in adults with pulmonary arterial hypertension (PAH) from unrepaired heart defects, including Eisenmenger syndrome. About 36 adults in Japan will be randomly assigned to receive either sotatercept plus standard care or standard care alone for 24 weeks. The main goal is to see if the combination helps people walk farther in six minutes.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 36 people

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

Started

Oct 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

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: * adults (≥18 years) * unrepaired ASD, VSD or PDA * ≥90 days of pulmonary vasodilator therapy; and either (i) pulmonary vascular resistance (PVR) ≥5 Wood units and mean pulmonary arterial pressure (mPAP) \> 20 mm Hg on right heart catheterization within 180 days, or (ii) echocardiographic tricuspid regurgitation velocity \>3.4 m/s with right-to-left/bidirectional shunt plus resting SpO₂ ≤92% consistent with cyanosis * baseline 6MWD ≥100 m * ability to complete questionnaires Exclusion Criteria: * WHO functional class IV; other unrepaired intracardiac shunts * severe renal/hepatic/parenchymal lung disease or LVEF \<40% * prior sotatercept use * contraindication to sotatercept per label * investigator-judged unsuitability

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Conditions

The condition(s) this trial relates to.

Eisenmenger syndrome pulmonary arterial hypertension

As listed by the trial registrant

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

Eisenmenger syndrome Pulmonary arterial hypertension of congenital heart disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Department of Cardiology, Keio University School of Medicine

    RECRUITING

    Tokyo, Japan

  • Department of Cardiology, Nagoya University Hospital

    RECRUITING

    Nagoya, Japan

  • Department of Cardiovascular Medicine, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University

    RECRUITING

    Okayama, Japan

  • Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine

    RECRUITING

    Kyoto, Japan

  • Department of Cardiovascular Medicine, Kyorin University School of Medicine

    RECRUITING

    Tokyo, Japan

  • Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

    RECRUITING

    Sendai, Japan

  • Division of Cardiovascular Medicine, Department of Internal Medicine, Showa University Graduate School of Medicine

    RECRUITING

    Tokyo, Japan

  • Division of Cardiovascular Medicine, Kobe University Hospital

    RECRUITING

    Kobe, Japan

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, Not Required For This Country, 8150014, Japan

  • The Second Department of Internal Medicine, University of Occupational and Environmental Health

    RECRUITING

    Fukuoka, Japan

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