NCT06693674

Effect of Sacubitril-Valsartan on Cardiac Structure and Function

Effect of Sacubitril-Valsartan on Cardiac Structure and Function in Adults With Congenital Heart Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-02-03
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-11-18
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study