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

Mayo Clinic

Status and phase: Enrolling; Phase 3

Conditions: Ebstein's Anomaly; Tetralogy of Fallot

Treatments: Drug: Entresto Pill; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06693674

5R01HL162830-02 (U.S. NIH Grant/Contract)

24-009099

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

Entresto

Experimental group

Treatment:

Drug: Entresto Pill

Placebo

Placebo Comparator group

Treatment:

Other: Placebo