Condition: Eisenmenger Syndrome · Pulmonary Arterial Hypertension of Congenital Heart Disease · Sponsor: Kazuya Hosokawa
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 every 3 weeks. All participants will have clinic visits and tests at the start, week 12, and week 24, including a 6-minute walk test (how far you can walk in 6 minutes), blood tests, questionnaires, and other heart-lung assessments used in routine PAH care. What are the possible benefits? Sotatercept improved exercise capacity and heart-lung measures in other PAH studies, but people with unrepaired heart defects were not included. This study may or may not help you directly, but it may help doctors learn how to use sotatercept safely in this group. What are the possible risks? Side effects see…
This description comes directly from the study's public registry record.
Kazuya Hosokawa, MD, PhD · +81-92-642-5360 · hosokawa.kazuya.712@m.kyushu-u.ac.jp
Keimei Yoshida, MD, PhD · yoshida.keimei.713@m.kyushu-u.ac.jp
Always discuss trial participation with your own doctor first.
| Kyushu University Hospital | Fukuoka, Not Required For This Country, Japan | Recruiting |
| The Second Department of Internal Medicine, University of Occupational and Environmental Health | Fukuoka, Japan | Recruiting |
| Division of Cardiovascular Medicine, Kobe University Hospital | Kobe, Japan | Recruiting |
| Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine | Kyoto, Japan | Recruiting |
| Department of Cardiology, Nagoya University Hospital | Nagoya, Japan | Recruiting |
| Department of Cardiovascular Medicine, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University | Okayama, Japan | Recruiting |
| Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine | Sendai, Japan | Recruiting |
| Department of Cardiology, Keio University School of Medicine | Tokyo, Japan | Recruiting |
| Department of Cardiovascular Medicine, Kyorin University School of Medicine | Tokyo, Japan | Recruiting |
| Division of Cardiovascular Medicine, Department of Internal Medicine, Showa University Graduate School of Medicine | Tokyo, Japan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07356778