drugset / Trial / NCT05991284

Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation

NCT05991284

Phase 4 Completed 84 enrolled Ziekenhuis Oost-Limburg Jessa Hospital · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

The main objective of this study is to assess the hemodynamic effects of sacubitril-valsartan in patients with heart failure with preserved ejection fraction and at least moderate atrial functional mitral regurgitation (AFMR), using a combination of cardiopulmonary exercise testing and stress echocardiography (referred to as CPETecho) at baseline and after six months of therapy. The patients included in this study will be randomly assigned to receive sacubitril-valsartan as an adjunct to standard medical care, as opposed to adhering solely to the standard of care which involves sodium-glucose cotransporter-2 (SGLT-2) inhibitor and mineralocorticoid receptor antagonist (MRA).

Timeline

Start
2024-02-29
Primary completion
2025-09-22
Completion
2026-05-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sacubitril-Valsartan Unknown 97 mg
Comparator Sacubitril-Valsartan Unknown 103 mg