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

Sponsor
Brigham and Women's Hospital
Study ID
NCT06536309
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Sacubitril-valsartan — DRUG
    Sacubitril-valsartan titrated to maximally targeted dose
  • Valsartan — DRUG
    Valsartan titrated to maximally targeted dose

Study Details

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 prognosis. Extracellular volume (ECV) is the most reproducible and best validated cardiac MRI measure of MIF. Sacubitril/valsartan reduces histological MIF in mice and levels of some extracellular matrix regulatory proteins in humans with HFpEF. However, the effect of sacubitril/valsartan on robust measures of MIF in humans is unknown. Demonstrating reductions in ECV with sacubitril/valsartan would clarify the mechanism of this approved medication. Given the borderline reduction in heart failure hospitalizations with sacubitril/valsartan and the heterogeneity of HFpEF pathophysiology, this result would suggest that neprilysin inhibition may particularly benefit HFpEF patients with greater MIF. The investigators propose a proof-of-concept clinical trial to evaluate the effect of neprilysin inhibition (sacubitril/valsartan vs valsartan alone) on cardiac MRI measures of fibrosis (principally ECV) and circulating protein levels.

Key Dates

First listed
Aug 2, 2024
Start date
Jul 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sacubitril/valsartan
    Patient randomized to the interventional arm will be treated with sacubitril/valsartan
  • Active Comparator: Valsartan
    Patient randomized to the active comparator arm will be treated with valsartan

Primary Outcome Measure

Change in extracellular volume by cardiac MRI [ Time Frame: 1 year ]

Central Contacts

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