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)

Q: Who can participate in NCT06658522?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06658522?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

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) (NCT06658522) is a Phase 4 interventional studying Pulmonary Arterial Hypertension PAH and Pulmonary Arterial Hypertension WHO Group I, sponsored by Amsterdam UMC, location VUmc. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Pulmonary arterial hypertension (PAH) is a progressive disease characterized by vascular remodelling resulting in elevated pressures in the pulmonary artery (PA). This elevated pressure ultimately leads to fulminant right heart failure. Current therapeutic options are limited and are centred around vasodilatory medications such as phosphodiesterase-5 inhibitors and prostacyclin. While these medications allow for the widening of blood vessels that are narrowed due to remodelling, they have no effect on the remodelling itself. Sotatercept is a novel medication which targets the BMPR2/TGF-β pathway and restore a pro- and anti- proliferative balance to ultimately counteract vascular remodelling. Recent phase 2 and 3 trials showed that treatment with sotatercept led to lower resistance and pressure in the pulmonary vasculature and improved exercise tolerance. However, these results were not coupled with an increase in cardiac output, a change that is seen with other PAH-medications with a primarily vasodilatory effect. These results suggest that cardiac work is reduced and cardiac efficiency is improved in patients being treated with sotatercept, in contrast with conventional PAH therapies. This is a potentially beneficial effect that may result in improved disease control in the long-term. Our study aims to explore the effect of sotatercept on cardiac work and function. We hypothesize that the effects of sotatercept are more beneficial for cardiac function than that of traditional PAH medications. All participants included in the trial will undergo a screening visit in which it will be checked that all inclusion criteria and no exclusion criteria are met. The screening visit involves a physical exam, blood draw, 6-minute walk test, right heart catheterization (RHC) and cardiac magnetic resonance imaging (cMRI) with contrast to assess fibrosis. Upon inclusion, all participants will receive a subcutaneous injection of sotatercept starting at a dose of 0.3 mg/kg. Participants will return to the hospital every three weeks for a blood draw, physical examination and an adverse event review. If the laboratory values (specifically haemoglobin and platelet counts) stay stable after the first dose, the dosage will be escalated to 0.7 mg/kg. The dose will not be escalated beyond 0.7 mg/kg. After 24 weeks of receiving sotatercept, there will be an end of treatment visit including a physical exam, 6-minute walk test, right heart catheterization (RHC) and cardiac magnetic resonance imaging (cMRI) with contrast material.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adult patients between 18-70 years of age 2. Able to provide signed willing to sign a consent form 3. WHO FC II to IV 4. NTproBNP \> 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 \> 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 Who Should NOT Join This Trial: 1. Any contraindication to treatment with sotatercept 2. Body weight \< 40 kg 3. Body mass index (BMI) \> 35kg/m2 4. Pregnancy, breastfeeding, or intention to become pregnant during the study 5. Recently started (\< 8 weeks prior to willing to sign a consent form signature) or planned cardio-pulmonary rehabilitation program 6. Known concomitant life-threatening disease with a life expectancy \< 12 months 7. Any condition likely to affect protocol or treatment compliance 8. Hospitalization for PAH within 3 months prior to willing to sign a consent form 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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 \> 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 \> 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 \< 40 kg 3. Body mass index (BMI) \> 35kg/m2 4. Pregnancy, breastfeeding, or intention to become pregnant during the study 5. Recently started (\< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program 6. Known concomitant life-threatening disease with a life expectancy \< 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 \< 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

Treatments Being Tested

DRUG

Sotatercept

Participants will receive open label subcutaneous sotatercept (starting dose, 0.3 mg per kilogram of body weight; target dose, 0.7 mg per kilogram) for 24 weeks

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Amsterdam UMC, location VUMC

Amsterdam, North Holland, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06658522), the sponsor (Amsterdam UMC, location VUmc), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06658522 clinical trial studying?

Who can participate in NCT06658522?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06658522?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06658522. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06658522. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.