Effect of Sacubitril-Valsartan on Cardiac Structure and Function

Phase 3RecruitingNCT06693674

Mayo Clinic45 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Congenital Heart Disease

Interventions

Entresto PillDRUG

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).

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Amanda Wozniak

CONTACT

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

Data from ClinicalTrials.gov

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