Effects of sotatercept on heart function and exercise in pulmonary arterial hypertension
Effect of Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension
PHASE4 · Mayo Clinic · NCT06409026
This study tests if the drug sotatercept can improve heart function and exercise ability in people with pulmonary arterial hypertension over 36 weeks.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06409026 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of the drug sotatercept on heart performance and quality of life in patients with pulmonary arterial hypertension over a 36-week period. Participants will undergo assessments to measure central cardiopulmonary performance and peripheral oxygen transport during exercise. The study aims to determine if sotatercept can improve these parameters in symptomatic patients. Eligible candidates must have specific heart function metrics and a diagnosis of pulmonary arterial hypertension confirmed by right heart catheterization.
Who should consider this trial
Good fit: Ideal candidates are symptomatic patients with pulmonary arterial hypertension classified as NYHA Class II-IV and specific heart function criteria.
Not a fit: Patients with recent heart-related events or those requiring immediate revascularization procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance heart function and quality of life for patients with pulmonary arterial hypertension.
How similar studies have performed: Other studies have shown promise with similar interventions in pulmonary arterial hypertension, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * NYHA Class II-IV. * LVEF ≥ 40 % within the preceding year. * No recent initiation of pulmonary vasodilator in the last 60 days. * Pulmonary arterial hypertension by right heart catheterization (Mean PA pressure ≥ 20 mmHg with PVR\>2 Wood units) with no evidence of heart failure with preserved ejection fraction (exercise PCWP \<25 mm Hg). * Symptomatic PAH patients with plan to undergo exercise RHC for reassessment of exertional symptoms. Exclusion Criteria * Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening. * Planned coronary, carotid, or peripheral artery revascularization. * Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease). * Wheelchair bound or orthopedic inability to exercise. * Chronic hypoxemia with inability to exercise without oxygen supplementation. * Skeletal muscle myopathy. * History of rhabdomyolysis. * Participation in any clinical trial of an approved or non-approved device for the treatment of pulmonary hypertension within 30 days before screening. * Receipt of any investigational medicinal product within 30 days before screening. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. * Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator. * Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Yogesh Reddy, MBBS — Mayo Clinic
- Study coordinator: Yogesh Reddy, MBBS
- Email: Reddy.Yogesh@mayo.edu
- Phone: 507-284-3687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Arterial Hypertension