A Study of Entresto in Tetralogy of Fallot (TOF) and Ebstein's Anomaly (EA)

Phase 3

Recruiting

• Conditions: Tetralogy of Fallot; Ebstein's Anomaly
• Interventions: Drug: Entresto Pill; Other: Placebo

• Registration Number: NCT06693674
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to compare changes in RV structure and function, biomarkers, and patient reported outcomes between TOF patients randomized to an ARNI vs placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-14
• Study First Posted: 2024-11-18
• Study Start: 2025-02-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• TOF or EA
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entresto	Entresto Pill	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Ventricular function	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.
Ventricular remodeling	Baseline, Week 52	Ventricular remodeling will be determined by Right Ventricle (RV) and Left Ventricle (LV) size and wall thickness acquired from CMRI and transthoracic echocardiographic imaging.
Change from baseline in Hs-Troponin	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.
Change from baseline in Galectin 3	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.
Change from baseline in Cystatin C	Baseline, Week 52	Cystatin C will be determined by blood specimen and measured in mg/L. A lower value reflects better kidney function.
Change in baseline in Soluble ST-2 (sST-2)	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.
Patient reported outcomes	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States