Effect of Sacubitril-Valsartan on Cardiac Structure and Function in Adults With Congenital Heart Disease
Mayo Clinic
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
- DrugEntresto 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).
- OtherPlacebo
Patients taking placebo tablets will take 1 tablet orally, twice daily
Location
- Mayo Clinic in RochesterRochester, Minnesota