Neprilysin Inhibition to Reduce Myocardial Fibrosis in Heart Failure With Preserved Ejection Fraction

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called sacubitril/valsartan to see if it can help reduce heart muscle scarring (myocardial fibrosis) in patients with heart failure who still have good heart function (known as heart failure with preserved ejection fraction or HFpEF). Researchers want to find out if this medication can lower a specific measurement related to heart scarring that can be seen through cardiac MRI scans. The trial will compare the effects of sacubitril/valsartan to another medication called valsartan alone to understand how well it works.

To participate, you need to be 50 years or older and have a doctor-confirmed diagnosis of heart failure, with a heart function measurement of 45% or higher. You must also be able to give informed consent and agree to follow the study's guidelines. However, there are some exclusions, such as having certain medical conditions or treatments that could interfere with the study. If you join, you can expect to undergo cardiac MRI scans and provide some blood samples to help researchers learn more about the medication's effects. It’s important to know that this trial is not yet recruiting participants, so it may take some time before it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged 50 years or older
• • Able to provide informed consent, as assessed by a physician investigator, and willing to comply with the study
• • Clinically confirmed diagnosis of heart failure
• • Left ventricular ejection fraction greater than or equal to 45% within 1 year by echocardiogram, cardiac MRI, or nuclear scan
• Exclusion Criteria:
• • Contraindication to MRI (metal prosthesis, implantable cardiac device, or severe claustrophobia)
• • Systolic blood pressure \< 100mm Hg, or \<110 mm Hg for patients not taking an ACE inhibitor or angiotensin receptor blocker
• • symptomatic hypotension
• • eGFR \< 30 mL/min/1.73m2 within 60 days of enrollment
• • Serum potassium \>5.2mmol/L within 60 days of enrollment, or \>5.0 mmol/L for patients not taking an ACE inhibitor or angiotensin receptor blocker
• • Myocardial infarction within 6 months of enrollment
• • Infiltrative or hypertrophic cardiomyopathy
• • History of cirrhosis, biliary cirrhosis, or cholestasis
• • History of angioedema
• • Pregnancy, planning pregnancy, or breastfeeding
• • Active treatment with lithium or a direct renin inhibitor