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Recruiting NCT06693674

Effect of Sacubitril-Valsartan on Cardiac Structure and Function

Phase III Interventional Congenital Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Entresto Pill, Placebo.
Who it may be relevant to
Registry conditions: Congenital Heart Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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).
  • Other Placebo
    Patients taking placebo tablets will take 1 tablet orally, twice daily

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06693674 · 24-009099 · 5R01HL162830-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗