Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
ID06658522

Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension

Led by Amsterdam UMC, location VUmc · Updated on 2025-09-22

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Amsterdam UMC, location VUmc

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pulmonary arterial hypertension (PAH) is a progressive condition marked by changes in the blood vessels leading to high pressure in the pulmonary artery, eventually causing severe right heart failure. Current treatments mainly focus on medications that widen blood vessels but do not address the underlying vessel changes. Sotatercept is a new medication being studied that targets specific pathways to restore balance and counteract these vessel changes, potentially improving heart function more effectively than traditional treatments. In this open-label, phase 4 study, participants with PAH will receive subcutaneous injections of sotatercept starting at 0.3 mg/kg, with the possibility to increase to 0.7 mg/kg based on blood test results. The treatment lasts for 24 weeks, during which participants visit the hospital every three weeks for blood tests, physical exams, and monitoring for any side effects. Before starting and after completing treatment, detailed heart assessments including right heart catheterization and cardiac magnetic resonance imaging are performed to evaluate heart function and structure. Participants will be involved in regular assessments such as physical exams, blood draws, a six-minute walk test to measure exercise capacity, and advanced heart imaging to track changes in heart function and fibrosis. Researchers will closely monitor cardiac work and coupling, as well as volumes and mass of both right and left ventricles. The study includes a 5-week follow-up after treatment ends to ensure safety and observe any lasting effects, with total participation spanning approximately 29 weeks from screening through follow-up.

CONDITIONS

Brief Title

Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension (RECOMPENSE)

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients between 18-70 years of age
  • Able to provide signed informed consent
  • WHO functional class II to IV
  • NTproBNP greater than 300 ng/L
  • Pulmonary arterial hypertension due to idiopathic or heritable causes
  • Hemodynamic diagnosis of PAH confirmed by right heart catheterization showing mean pulmonary arterial pressure above 20 mmHg, pulmonary capillary wedge pressure or left ventricular end diastolic pressure 15 mmHg or less, and pulmonary vascular resistance 4 Wood units or higher
  • Stable dose of oral diuretics for at least 1 month before screening if applicable
  • Stable background therapy for at least 3 months before screening
  • Women of childbearing potential must have a negative pregnancy test and agree to use reliable contraception
  • Males must agree to use condoms during sexual contact with females of childbearing potential and avoid blood or sperm donation during and for 16 weeks after the study
Not Eligible

You will not qualify if you...

  • Contraindication to treatment with sotatercept
  • Body weight less than 40 kg
  • Body mass index over 35 kg/m2
  • Pregnancy, breastfeeding, or planning pregnancy during the study
  • Recently started or planned cardio-pulmonary rehabilitation less than 8 weeks before consent
  • Life-threatening disease with life expectancy less than 12 months
  • Conditions affecting protocol or treatment compliance
  • Hospitalization for PAH within 3 months before consent
  • Left atrial volume per body surface area 43 mL/m2 or higher
  • Valvular disease grade 2 or higher
  • History of pulmonary embolism or deep vein thrombosis
  • Moderate to severe chronic obstructive pulmonary disease
  • Moderate to severe restrictive lung disease
  • Significant coronary artery disease history
  • Diabetes mellitus
  • Active cancer
  • Systolic blood pressure less than 90 mmHg
  • Need for dialysis
  • Responders to acute vasoreactivity testing
  • Treatment with another investigational drug within 3 months prior to study
  • Claustrophobia
  • Permanent cardiac pacemaker or internal cardioverter
  • Metallic implants such as defibrillator, neurostimulator, or infusion device
  • Atrial fibrillation, frequent premature ventricular or atrial contractions, or any condition interfering with cardiac gating during cardiac MRI
  • History of major bleeding
  • Hemoglobin above upper limit of normal for age and gender

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - 24 weeks

Participants receive subcutaneous sotatercept injections to evaluate effects on right ventricular function and dimensions in pulmonary arterial hypertension.

Visits for sotatercept dosing and assessments including right heart catheterization, cardiac MRI, physician assessment, and blood sampling at the start and end of treatment

Follow-up

Duration - 5 weeks

Participants are observed for 5 weeks after completing treatment to monitor health status.

1 follow-up visit

Trial Site Locations

Total: 1 location

1

Amsterdam UMC, location VUMC

Amsterdam, North Holland, Netherlands, 1081HV

Actively Recruiting

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Research Team

H

Harm Jan Bogaard, M.D., PhD

E

Eszter N Toth, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Perspectives on novel therapeutic strategies for right heart failure in pulmonary arterial hypertension: lessons from the left heart.

M L Handoko, F S de Man, C P Allaart...

https://pubmed.ncbi.nlm.nih.gov/20956170