Real-world sotatercept treatment for pulmonary hypertension

Sotatercept Pulmonary Hypertension Observational Registry

This project will document how sotatercept works for adults with pulmonary hypertension treated at the Mayo Clinic to see if real-world use matches expectations.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT06751082 on ClinicalTrials.gov

What this trial studies

This observational project collects real-world data on adults with pulmonary hypertension who receive sotatercept at the Mayo Clinic in Rochester, Minnesota. Investigators will record clinical outcomes, safety events, dosing patterns, and tolerability from routine clinic visits and medical records without altering standard care. Participation requires the capacity to provide informed consent and does not introduce experimental interventions. The aim is to describe initial clinical experience to help clinicians understand how sotatercept performs outside of controlled trials.

Who should consider this trial

Good fit: Adults aged 18 or older with pulmonary hypertension who are being treated with sotatercept at the Mayo Clinic Pulmonary Hypertension clinic and can consent are ideal candidates.

Not a fit: Patients under 18, those not receiving sotatercept, those treated outside the Mayo Clinic, or individuals lacking capacity to consent are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, the findings could give clinicians practical information about sotatercept's safety and effectiveness in routine care, informing treatment decisions.

How similar studies have performed: Prior randomized clinical trials of sotatercept in pulmonary arterial hypertension have shown promising improvements in hemodynamics and exercise capacity, so this real-world report builds on those trial results.

Eligibility criteria

Inclusion Criteria:

* Adults age 18 or greater who are being treated with sotatercept in the Mayo Pulmonary hypertension clinic.

Exclusion Criteria:

* Adults lacking capacity to consent

Where this trial is running

Rochester, Minnesota

• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Robert Frantz, M.D. — Mayo Clinic
• Study coordinator: Hayden Halbach, M.B.A.

Conditions: Pulmonary Hypertension