NCT05991284

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Ziekenhuis Oost-Limburg · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Heart Failure With Preserved Ejection Fraction
• Functional Mitral Regurgitation

Interventions

Type	Name	Description
DRUG	Sacubitril-valsartan	sacubitril-valsartan (target dose 97/103 mg twice daily)
DRUG	Standard of care	including SGLT-2 inhibitor and MRA

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-09-22
• Completion: 2026-05-01
• First posted: 2023-08-14
• Last updated: 2025-12-19

Locations

1 site across 1 country: Belgium