Status:
RECRUITING
A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy
Lead Sponsor:
Kazuya Hosokawa
Conditions:
Eisenmenger Syndrome
Pulmonary Arterial Hypertension of Congenital Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 d...
Eligibility Criteria
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
Key Trial Info
Start Date :
October 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07356778
Start Date
October 7 2025
End Date
April 30 2028
Last Update
January 21 2026
Active Locations (10)
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1
Kyushu University Hospital
Fukuoka, Not Required For This Country, Japan, 8150014
2
The Second Department of Internal Medicine, University of Occupational and Environmental Health
Fukuoka, Japan
3
Division of Cardiovascular Medicine, Kobe University Hospital
Kobe, Japan
4
Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Kyoto, Japan