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Effect of Sacubitril-Valsartan on Cardiac Structure and Function

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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Entresto Pill (drug)
• Placebo (other)

Sponsor: Mayo Clinic · Participants: 45 · Started: Feb 3, 2025

Contact the study team

• Amanda Wozniak · Phone: 507-266-1976

Official record on ClinicalTrials.gov — NCT06693674

Locations in the U.S.

Conditions

• Congenital Heart Defects

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.