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
Conditions
Congenital Heart Disease
Locations
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States