Using sacubitril-valsartan for heart failure with preserved ejection fraction and mitral valve issues
Sacubitril-Valsartan in Heart Failure with Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation
This study is testing if adding the heart medication sacubitril-valsartan to standard care can help people with heart failure and mitral valve problems feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Ziekenhuis Oost-Limburg Academic / other |
| Locations | 1 site (Genk) |
| Trial ID | NCT05991284 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of sacubitril-valsartan on patients suffering from heart failure with preserved ejection fraction and moderate functional mitral regurgitation. Participants will undergo cardiopulmonary exercise testing and stress echocardiography to assess hemodynamic changes at the start and after six months of treatment. Patients will be randomly assigned to receive sacubitril-valsartan alongside standard medical care or to continue with standard care alone. The goal is to determine if the addition of this medication improves patient outcomes compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with heart failure symptoms and moderate functional mitral regurgitation.
Not a fit: Patients with severe comorbid conditions or those already on sacubitril-valsartan therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for patients with heart failure and mitral valve regurgitation.
How similar studies have performed: While there have been studies on sacubitril-valsartan, this specific application in heart failure with preserved ejection fraction and functional mitral regurgitation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Genk
- Ziekenhuis Oost-Limburg — Genk, Belgium (Recruiting)
Study contacts
- Study coordinator: Philippe Bertrand, MD, PhD
- Email: philippe.bertrand@zol.be
- Phone: 089/32 71 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.