Effect of Sacubitril-Valsartan on Cardiac Structure and Function

NCT06693674 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 24-0090995R01HL162830-02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Ventricular function

  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.

  Baseline, Week 52

• Ventricular structure

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

  Baseline, Week 52

• Change from baseline in Hs-Troponin

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

  Baseline, Week 52

• Change from baseline in Galectin 3

  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.

  Baseline, Week 52

• Change from baseline in Cystatin C

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

  Baseline, Week 52

• Change in baseline in Soluble ST-2 (sST-2)

  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.

  Baseline, Week 52

• Patient reported outcomes

  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.

  Baseline, Week 52

Study Arms (2)

Entresto

EXPERIMENTAL

Drug: Entresto Pill

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

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).

Entresto

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Congenital Heart Disease Diagnosis
• Age 18 or Older

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Alexander Egbe

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Wozniak

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)