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ACTIVE NOT RECRUITING
NCT05991284
PHASE4

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

Sponsor: Ziekenhuis Oost-Limburg

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2024-02-29

Completion Date

2026-05-01

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

DRUG

Sacubitril-valsartan

sacubitril-valsartan (target dose 97/103 mg twice daily)

DRUG

Standard of care

including SGLT-2 inhibitor and MRA

Locations (1)

Ziekenhuis Oost-Limburg

Genk, Belgium