Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension

NCT06409026 | Completed Phase 4 FDA Drug

• 1 other identifier: 24-002570
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if the drug sotatercept given for 36 weeks improves the functioning of the heart and improves quality of life.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise

  Peak exercise pulmonary arterial mean pressure/ Cardiac output (mm Hg/L/min)

  Baseline, Week 24

Secondary Outcomes (18)

• Oxygen Consumption (VO2)

  Baseline, 24 weeks

• Single leg blood flow at peak exercise

  Baseline, 24 weeks

• Pulmonary vascular resistance at rest

  Baseline, 24 weeks

• Pulmonary vascular resistance at peak exercise

  Baseline, 24 weeks

• Pulmonary arterial (PA) compliance at rest

  Baseline, 24 weeks

Study Arms (1)

Sotatercept Therapy

EXPERIMENTAL

All participants will receive 36 weeks of sotatercept therapy. Sotatercept is administered as a subcutaneous injection once every 3 weeks.

Drug: Sotatercept

Interventions

Sotatercept DRUG

As per FDA indications, sotatercept will be administered as 0.3 mg/kg injection for the first dose followed by 0.7 mg/kg injections for subsequent doses.

Sotatercept Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Reddy YNV, Frantz RP, Miranda WR, Harada T, Kazui S, Borlaug BA. Sotatercept in Pulmonary Arterial Hypertension: Central, Hematologic, and Peripheral Mechanisms of Benefit. J Am Coll Cardiol. 2026 Mar 2:S0735-1097(26)05633-0. doi: 10.1016/j.jacc.2026.02.5103. Online ahead of print.

  PMID: 41885673 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yogesh Reddy, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: July 5, 2024
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)