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NCT Number: NCT06693674

Effect of Sacubitril-Valsartan on Cardiac Structure and Function

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Alexander C Egbe

PRINCIPAL_INVESTIGATOR

Amanda Wozniak

CONTACT

[email protected]

507-266-1976

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entresto Pill

Drug

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

Other

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

Primary outcomes

  1. Ventricular function

    Time frame: Baseline, Week 52

    Ventricular Function will be determined by indices of Right Ventricle (RV) and Left Ventricle (LV) systolic and diastolic function indices acquired from CMRI and transthoracic echocardiographic imaging.

  2. Ventricular structure

    Time frame: Baseline, Week 52

    Ventricular structure will be determined by Right Ventricle (RV) and Left Ventricle (LV) size and wall thickness acquired from CMRI and transthoracic echocardiographic imaging.

  3. Change from baseline in Hs-Troponin

    Time frame: Baseline, Week 52

    Hs-Troponin will be determined by blood specimen and will be measured in ng/L. A higher value indicates damage to the heart.

  4. Change from baseline in Galectin 3

    Time frame: Baseline, Week 52

    Galectin 3 will be determined by blood specimen and will be measure in ng/mL. A higher value indicates a higher severity of heart disease.

  5. Change from baseline in Cystatin C

    Time frame: Baseline, Week 52

    Cystatin C will be determined by blood specimen and measured in mg/L. A lower value reflects better kidney function.

  6. Change in baseline in Soluble ST-2 (sST-2)

    Time frame: Baseline, Week 52

    Soluble ST-2 (sST-2) will be determined by blood specimen and measured in ng/mL. A higher value indicates a higher severity of heart failure.

  7. Patient reported outcomes

    Time frame: Baseline, Week 52

    Patient reported outcomes will be determined by a quality-of-life questionnaire. A self-assessment survey to assess the extent to which heart failure (HF) affects the patient's activities of daily living and quality of life. The questionnaire is 12 questions and a lower score reflects more severe the limitations on daily life.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Wozniak

CONTACT

[email protected]

507-266-1976

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2024
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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