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

NCT ID: NCT05991284

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-05-01

Brief Summary

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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).

Detailed Description

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Conditions

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Heart Failure With Preserved Ejection Fraction Functional Mitral Regurgitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, Investigator-initiated, Prospective, Randomized trial with Open Blinded Endpoint
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinded core echocardiography laboratory

Study Groups

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Intervention arm

Sacubitril-Valsartan (target dose 97/103 mg twice daily) on top of standard of care (including SGLT-2 inhibitor and MRA)

Group Type ACTIVE_COMPARATOR

Sacubitril-valsartan

Intervention Type DRUG

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

Standard of care

Intervention Type DRUG

including SGLT-2 inhibitor and MRA

Control arm

Standard of care (including SGLT-2 inhibitor and MRA)

Group Type PLACEBO_COMPARATOR

Standard of care

Intervention Type DRUG

including SGLT-2 inhibitor and MRA

Interventions

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Sacubitril-valsartan

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

Intervention Type DRUG

Standard of care

including SGLT-2 inhibitor and MRA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Systolic blood pressure \< 100 mmHg.
* Potassium ≥ 5.2 mmol/L.
* Estimated Glomerular Filtration Rate ≤ 25 ml/min/1.73m².
* History of angioedema or unacceptable side effects during receipt of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB).
* Structural mitral valve disease and previous or planned mitral valve intervention.
* Already receiving angiotensin receptor neprilysin inhibitor (ARNI, sacubitril-valsartan) therapy.
* Severe comorbid condition limiting life expectancy \< 24 months or inability to perform a maximal CPETecho.
* Myocardial infarction, unstable angina, coronary revascularization within 12 weeks prior enrolment.
* Severe aortic, tricuspid or pulmonary valve disease.
* Pregnancy, lactation, or use of any method of contraception that is not highly effective.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Z-2023036

Identifier Type: -

Identifier Source: org_study_id