NCT05991284CompletedPhase 4
Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 1 Aug 2023
- Start date
- 29 Feb 2024
- Primary completion date
- 22 Sept 2025
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Diseases
- Heart failure
- NCT number
- NCT05991284
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 84
- From 29 Feb 2024 to the primary completion date, 22 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Structural mitral valve disease and previous or planned mitral valve intervention.
- Already receiving angiotensin receptor neprilysin inhibitor (ARNI, sacubitril-valsartan) therapy.
- Myocardial infarction, unstable angina, coronary revascularization within 12 weeks prior enrolment.
Other illness
- History of angioedema or unacceptable side effects during receipt of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB).
- Severe comorbid condition limiting life expectancy \< 24 months or inability to perform a maximal CPETecho.
- Severe aortic, tricuspid or pulmonary valve disease.
Lab values
- Potassium ≥ 5.2 mmol/L.
Other
- Systolic blood pressure \< 100 mmHg.
- Estimated Glomerular Filtration Rate ≤ 25 ml/min/1.73m².
- Pregnancy, lactation, or use of any method of contraception that is not highly effective.
Who the study is looking for
- 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.
Age in the registry: 18 years to 95 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.