Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve… (NCT05991284) | Clinical Trial Compass
CompletedPhase 4
Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation
Belgium84 participantsStarted 2024-02-29
Plain-language 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).
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at sacubitril-valsartan specifically for people who have both heart failure with preserved ejection fraction AND functional mitral regurgitation — do I have both of those conditions, and would that combination make this drug worth discussing for my situation?
2The trial measured something called the mean pulmonary arterial pressure over cardiac output slope using a combined exercise and echocardiogram test — can you explain what that measurement tells us about how my heart is actually functioning under stress, and whether my current workup has captured that?
3Since this is a Phase 4 trial that has already been completed, does that mean there may be results available soon, and would those findings change how you'd think about prescribing sacubitril-valsartan for me compared to what's already approved?
4Are there standard treatments for functional mitral regurgitation alongside heart failure with preserved ejection fraction that I should try first, or would sacubitril-valsartan potentially address both problems at once in a way that makes it a stronger option for someone like me?
5Given that this trial is now completed, is there any way to find out what the results showed, and how would those results factor into your recommendation about my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in mean pulmonary arterial pressure over cardiac output slope assessed by CPETecho