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Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 70

Sotatercept to support right ventricular function in pulmonary arterial hypertension

Official title: RECOMPENSE: 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

Run by Amsterdam UMC, location VUmc · NCT06658522 · Data updated 2026-11-12

This research will try sotatercept injections in adults with PAH to see if the medicine helps the right side of the heart work better.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment20 (estimated)
SponsorAmsterdam UMC, location VUmc
Academic / other
Locations1 site (Amsterdam, North Holland)
StatusRecruiting
StartedMay 14, 2025
Main results expectedMay 1, 2026
Study endsMay 1, 2026
Registry record updatedSeptember 22, 2025
Trial IDNCT06658522 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–70 years with idiopathic or heritable PAH (WHO Group I), WHO functional class II–IV, NT‑proBNP >300 ng/L, and hemodynamic confirmation by right heart catheterization (mPAP >20 mmHg, PCWP/LVEDP ≤15 mmHg, PVR ≥4 WU) who are on stable background PAH therapy are ideal candidates.

Probably not a fit

Patients with PAH due to left heart disease or other excluded etiologies, those with PCWP/LVEDP >15 mmHg, PVR <4 WU, outside the 18–70 age range, with unstable background therapy, or with contraindications to right heart catheterization or sotatercept are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, single-arm, open-label phase 4 study at Amsterdam UMC will enroll 20 adults with idiopathic or heritable PAH on stable background therapy. Participants will receive subcutaneous sotatercept (starting 0.3 mg/kg, target 0.7 mg/kg) and undergo invasive pressure–volume loop measurements via right heart catheterization to measure load-independent right ventricular function and RV–PA coupling. The study will compare pre-treatment and on-treatment RV contractility, dimensions, and hemodynamics including mPAP and PVR, alongside safety and biomarker monitoring. Results will clarify whether sotatercept's vascular effects translate into direct improvements in intrinsic RV performance.

Why it matters

Potential benefit: If successful, sotatercept could lower pulmonary vascular resistance and improve right ventricular function, potentially reducing symptoms and slowing progression to right heart failure.

How similar studies have gone: Prior phase 2 and 3 trials of sotatercept showed significant reductions in PVR and improved exercise capacity, but produced only minimal increases in cardiac output, leaving direct effects on intrinsic RV function less clear.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Adult patients between 18-70 years of age
2. Able to provide signed informed consent
3. WHO FC II to IV
4. NTproBNP \&gt; 300 ng/L
5. PAH etiology belonging to one of the following groups (Nice classification):

   * Idiopathic PAH
   * Heritable PAH
6. Hemodynamic diagnosis of PAH confirmed by RHC during screening showing:

   * mPAP \&gt; 20 mmHg
   * Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg
   * PVR ≥ 4WU (320 dyn.sec.cm-5)
7. For patients treated with oral diuretics, treatment dose must have been stable at least 1 month prior to RHC during the screening period
8. All patients are on stable background therapy at least 3 months prior to RHC during the screening period
9. Women of childbearing potential must have a negative pregnancy test at screening and agree to use reliable methods of contraception
10. Males must agree to use a condom during sexual contact with a pregnant female or female of childbearing potential while participating in the study. Males should refrain from donating blood or sperm for the duration for the study and for 16 weeks after last dose of sotatercept

Exclusion Criteria:

1. Any contraindication to treatment with sotatercept
2. Body weight \&lt; 40 kg
3. Body mass index (BMI) \&gt; 35kg/m2
4. Pregnancy, breastfeeding, or intention to become pregnant during the study
5. Recently started (\&lt; 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program
6. Known concomitant life-threatening disease with a life expectancy \&lt; 12 months
7. Any condition likely to affect protocol or treatment compliance
8. Hospitalization for PAH within 3 months prior to informed consent signature
9. Left atrial volume per body surface area ≥ 43mL/m2 by echocardiography or CMR
10. Valvular disease grade 2 or higher
11. History of pulmonary embolism or deep vein thrombosis
12. Documented moderate to severe chronic obstructive pulmonary disease
13. Documented moderate to severe restrictive lung disease
14. Historical evidence of significant coronary artery disease
15. Diabetes mellitus
16. Active cancer
17. Systolic blood pressure \&lt; 90 mmHg
18. Need for dialysis
19. Responders to acute vasoreactivity testing based on medical history
20. Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation)
21. Claustrophobia
22. Permanent cardiac pacemaker, automatic internal cardioverter
23. Metallic implant (e.g. defibrillator, neurostimulator, hearing aid, infusion device)
24. Atrial fibrillation, multiple premature ventricular or atrial contractions , or any other condition that would interfere with proper cardiac gating during CMR.
25. History of major bleeding
26. Hemoglobin above ULN for age and gender

Where it's running

  • Amsterdam UMC, location VUMC
    Amsterdam, North Holland, Netherlands     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.