Recruiting
Phase 3

Entresto

Sponsor:

Mayo Clinic

Code:

NCT06693674

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Entresto Pill

Placebo

Study Details

Brief 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.

Conditions

Congenital Heart Disease

Study ID

NCT06693674

Start date

Feb 3, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Entresto

placebo comparator: Placebo

Interventions

Entresto 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).

Placebo

Patients taking placebo tablets will take 1 tablet orally, twice daily

Primary outcome measure

  • Ventricular function [ Time Frame: Baseline, Week 52 ]
  • Ventricular structure [ Time Frame: Baseline, Week 52 ]
  • Change from baseline in Hs-Troponin [ Time Frame: Baseline, Week 52 ]
  • Change from baseline in Galectin 3 [ Time Frame: Baseline, Week 52 ]
  • Change from baseline in Cystatin C [ Time Frame: Baseline, Week 52 ]
  • Change in baseline in Soluble ST-2 (sST-2) [ Time Frame: Baseline, Week 52 ]
  • Patient reported outcomes [ Time Frame: Baseline, Week 52 ]

Central Contacts and Locations

Central contacts

Amanda Wozniak

507-266-1976Wozniak.Amanda@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amanda Wozniak

507-266-1976Wozniak.Amanda@mayo.edu

Principal Investigator:

Alexander C Egbe

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 7, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-10-07.