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Effect of Sacubitril-Valsartan on Cardiac Structure and Function

NCT06693674 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-10-07

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Heart Disease

Interventions

DRUG

Entresto Pill

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).

OTHER

Placebo

Patients taking placebo tablets will take 1 tablet orally, twice daily

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Alexander Egbe · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06693674 on ClinicalTrials.gov