Status:
NOT_YET_RECRUITING
Neprilysin Inhibition to Reduce Myocardial Fibrosis in Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Heart Failure With Preserved Ejection Fraction
Myocardial Fibrosis
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief Summary
Cardiac magnetic resonance imaging (MRI) measures of myocardial interstitial fibrosis (MIF) are elevated in heart failure with preserved ejection fraction (HFpEF) patients and associated with poor pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06536309
Start Date
January 1 2026
End Date
September 1 2029
Last Update
January 7 2026
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