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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: f
View:

• Age \> 18 years.

• New York Heart Association class II to IV.

• Written informed consent.

• Left ventricular (LV) ejection fraction ≥ 50%.

• Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptides.

• ≥ moderate functional MR assessed by transthoracic echocardiography within the previous year.

Locations
Other Locations
Belgium
Ziekenhuis Oost-Limburg
RECRUITING
Genk
Contact Information
Primary
Philippe Bertrand, MD, PhD
philippe.bertrand@zol.be
089/32 71 40
Backup
Sebastiaan Dhont, MD
sebastiaan.dhont@zol.be
+32471626094
Time Frame
Start Date: 2024-02-29
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 110
Treatments
Active_comparator: Intervention arm
Sacubitril-Valsartan (target dose 97/103 mg twice daily) on top of standard of care (including SGLT-2 inhibitor and MRA)
Placebo_comparator: Control arm
Standard of care (including SGLT-2 inhibitor and MRA)
Sponsors
Collaborators: Jessa Hospital
Leads: Ziekenhuis Oost-Limburg

This content was sourced from clinicaltrials.gov