Effect of Sacubitril-Valsartan on Cardiac Structure and Function

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06693674
Phase
PHASE3
Status
Recruiting
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Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Entresto Pill — DRUG
    Patients will take a 24/26 mg dose orally, twice daily, for weeks 1 and 2, 49/51 mg orally, twice daily, for weeks 3 and 4, and 97/103 mg orally twice daily, for the remaining 48 weeks (total duration: 52 weeks).
  • Placebo — OTHER
    Patients taking placebo tablets will take 1 tablet orally, twice daily

Study Details

The purpose of this study is to compare changes in cardiac structure and function, biomarkers, and patient reported outcomes between adults with congenital heart disease (ACHD) randomized to angiotensin receptor-neprilysin inhibitor (ARNI) therapy vs placebo.

Key Dates

Start date
Feb 3, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Entresto
  • Placebo Comparator: Placebo

Primary Outcome Measure

Ventricular function [ Time Frame: Baseline, Week 52 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Amanda Wozniak
[email protected]
507-266-1976
Alexander C Egbe (PRINCIPAL_INVESTIGATOR)

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