RecruitingPhase 4NCT07140484

Sotatercept in Pulmonary Arterial Hypertension

A Single-arm, Open-label Phase IV Study to Evaluate the Effectiveness of Sotatercept in Improving Pulmonary Vascular Recruitment in Patients With Pulmonary Arterial Hypertension (PAH)

Sponsor

University of Alberta

Enrollment

27 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

Pulmonary Artery Hypertension

Summary

The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension. Participants will be asked to: * Take Sotatercept every 21 days (±3 days) * Each participant will be enrolled in the study for 29 Weeks * Visit the clinic 18 times * Have a physical exam * Perform assessments of lung function and exercise tests * Have an ultrasound of their heart * Have blood draws done at regular intervals The main objectives of the study are: Primary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise. Secondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing sotatercept — a drug that helps regulate abnormal blood vessel growth in the lungs — in people with pulmonary arterial hypertension (PAH), a condition where the arteries in the lungs become narrowed and the heart must work harder to pump blood. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with PAH (confirmed by a right heart catheterization procedure) - Your PAH falls into a recognized subtype (idiopathic, heritable, drug/toxin-induced, or associated with connective tissue disease or repaired heart defects) - You are experiencing symptoms (WHO Functional Class II or III — moderate limitations with activity) - You are already on at least 2 background PAH medications at stable doses **You may NOT be eligible if...** - You have pulmonary hypertension caused by left heart disease, lung disease, or blood clots - You have severe liver disease - You are pregnant or planning pregnancy - You have recently started a new PAH medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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