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NCT06693674PHASE3Recruiting

Effect of Sacubitril-Valsartan on Cardiac Structure and Function

Mayo Clinic

Start Date

2/3/2025

Completion Date

12/1/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Congenital Heart Disease Diagnosis * Age 18 or Older Exclusion Criteria: * Stage IV chronic kidney disease defined as creatinine clearance \<30 ml/min * Hyperkalemia defined as serum potassium \>5.2 mmol/l, * Hypotension defined as systolic blood pressure \<100 mmHg, * History of angioedema related to previous ACE or ARB therapy * Patients diagnosed with diabetes using Aliskiren, * Pregnancy. * Drug Therapies * Amifostine * Droperidol * Dantrolene * CYP3A4 Inhibitors * Obinutuzumab * Aliskiren * Lithium * Sparsentan * ACE inhibitor * ARB * ARNI

Interventions

DRUG

Entresto Pill

OTHER

Placebo

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Conditions

Congenital Heart Disease

Locations

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States