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New treatment option for Eisenmenger Syndrome
Official title A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy
ClinicalTrials.gov ID: NCT07356778
What this study is testing
What is Sotatercept?
Sotatercept is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for eisenmenger syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 24 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- baseline 6MWD ≥100 m
- ability to complete questionnaires
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fukuoka, Not Required For This Country, Japan
- Fukuoka, Japan
- Kobe, Japan
- Kyoto, Japan
- Nagoya, Japan
- Okayama, Japan
- Sendai, Japan
- Tokyo, Japan
Compensation & support
Travel support may be available. Some study costs may be covered. A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you, and this study mentions travel support. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fukuoka, Not Required For This Country, Japan; Fukuoka, Japan; Kobe, Japan; Kyoto, Japan; Nagoya, Japan; Okayama, Japan and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.