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

Description

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.

Conditions

Tetralogy of Fallot, Ebstein's Anomaly

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Study Overview

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Study Details

Study overview

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.

Role of Sacubitril-Valsartan for Right Ventricular Reverse Remodeling in Adults with Tetralogy of Fallot and Ebstein's Anomaly: a Randomized Controlled Pilot Clinical Trial

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

Condition
Tetralogy of Fallot
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * TOF or EA
  • * Age 18 or Older
  • * 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
  • * Simvastatin \>20mg
  • * Aliskiren
  • * Lithium
  • * Sparsentan
  • * ACE inhibitor
  • * ARB
  • * ARNI

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Alexander Egbe, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2026-12