🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy

RecruitingPhase 4Ages 18 Years - anyAllKazuya Hosokawa
NCT07356778 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

What is this study about? This study will test whether adding sotatercept to usual medicines for pulmonary arterial hypertension (PAH) can help adults who have PAH due to unrepaired congenital heart defects (atrial or ventricular septal defect, or patent ductus arteriosus), including Eisenmenger syndrome. These conditions often cause long-standing changes in the lung blood vessels and low oxygen levels. Who can join? About 36 adults (age ≥18 years) in Japan whose PAH has not improved enough with pulmonary vasodilators may join. People with very severe symptoms (WHO class IV) or other serious illnesses will not be enrolled. What will happen if I join? Participants will be randomly assigned (like a coin flip, in a 2:1 ratio) to: Sotatercept + vasodilator-based PAH care, or vasodilator-based PAH care alone. The study lasts 24 weeks. Those who receive sotatercept will have injections ev

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • Sotatercept
  • vasodilator-based PAH therapy
📍

Where

10 sites
Kyushu University Hospital
Fukuoka, Japan
The Second Department of Internal Medicine, University of Occupational and Environmental Health
Fukuoka, Japan
Division of Cardiovascular Medicine, Kobe University Hospital
Kobe, Japan
Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Kyoto, Japan
Department of Cardiology, Nagoya University Hospital
Nagoya, Japan
Department of Cardiovascular Medicine, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Okayama, Japan
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Sendai, Japan
Department of Cardiology, Keio University School of Medicine
Tokyo, Japan

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy