Effect of Sacubitril-Valsartan on Cardiac Structure and Function

Last updated: October 2, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

3

Condition

Heart Defect

Congenital Heart Disease

Pentalogy Of Cantrell

Treatment

Placebo

Entresto Pill

Clinical Study ID

NCT06693674
24-009099
5R01HL162830-02
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Congenital Heart Disease Diagnosis

  • Age 18 or Older

Exclusion

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

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 03, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

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