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

Launched by ZIEKENHUIS OOST-LIMBURG · Aug 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called sacubitril-valsartan in patients who have heart failure with preserved ejection fraction (HFpEF) and moderate mitral valve regurgitation (a condition where blood leaks backward into the heart). The goal is to see how well this medication works in improving heart function and overall health over a six-month period. Participants will undergo some tests, including exercise testing and heart ultrasound, before and after the treatment to assess any changes.

To be eligible for this trial, participants must be adults over 18 years old who have specific heart-related symptoms and evidence of heart dysfunction. They should also have a certain level of heart efficiency and moderate mitral valve regurgitation. However, those with certain health conditions, such as low blood pressure or severe kidney issues, will not be able to participate. Individuals who join the study can expect to receive either sacubitril-valsartan along with standard treatment or standard treatment alone, with regular check-ups to monitor their progress. This trial is currently recruiting participants, and it is important for anyone considering joining to discuss it with their healthcare provider to ensure it is a good fit for them.

Gender

ALL

Eligibility 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.