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RECOMPENSE: Right vEntricular COMPENsation with SotatercEpt. A prospective single arm open label phase IV study to evaluate the effects of sotatercept on right ventricular function in pulmonary arterial hypertension

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512543-23-00
Acronym
2024-512543-23-00
Enrollment
20
Registered
2025-04-14
Start date
2025-05-14
Completion date
Unknown
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension

Brief summary

Change in power per beat after 24 weeks of sotatercept, Change in right ventricular pulmonary artery coupling index (Ees/Ea) after 24 weeks of sotatercept

Detailed description

∆ Right Ventricular End Diastolic Volume (RVEDV), ∆ Right Ventricular End Systolic Volume (RVESV), ∆ Right Ventricular Ejection Fraction (RVEF), ∆ Right Ventricular mass, ∆ Stroke Volume determined from aortic flow, ∆ Left Ventricular End Diastolic Volume (LVEDV), ∆ Left Ventricular End Systolic Volume (LVESV), ∆ Left Ventricular Ejection Fraction (LVEF), ∆ Left ventricular mass, ∆ End-systolic elastance (Ees), ∆ Arterial elastance (Ea), ∆ End diastolic elastance (Eed), ∆ Extracellular volume as measured by cardiac magnetic resonance imaging

Interventions

DRUGWinrevair 60 mg powder for solution for injection

Sponsors

Amsterdam UMC Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Change in power per beat after 24 weeks of sotatercept, Change in right ventricular pulmonary artery coupling index (Ees/Ea) after 24 weeks of sotatercept

Secondary

MeasureTime frame
∆ Right Ventricular End Diastolic Volume (RVEDV), ∆ Right Ventricular End Systolic Volume (RVESV), ∆ Right Ventricular Ejection Fraction (RVEF), ∆ Right Ventricular mass, ∆ Stroke Volume determined from aortic flow, ∆ Left Ventricular End Diastolic Volume (LVEDV), ∆ Left Ventricular End Systolic Volume (LVESV), ∆ Left Ventricular Ejection Fraction (LVEF), ∆ Left ventricular mass, ∆ End-systolic elastance (Ees), ∆ Arterial elastance (Ea), ∆ End diastolic elastance (Eed), ∆ Extracellular volume as measured by cardiac magnetic resonance imaging

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026