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NCT06693674 | NOT YET RECRUITING | Tetralogy of Fallot

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

Mayo Clinic

Information provided by (Responsible Party):

Alexander C. Gun

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.

Condition or disease

Tetralogy of Fallot

Ebstein's Anomaly

Intervention/treatment

Entresto Pill

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 45 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
  • * Simvastatin \>20mg
  • * Aliskiren
  • * Lithium
  • * Sparsentan
  • * ACE inhibitor
  • * ARB
  • * ARNI
A Study of Entresto in Tetralogy of Fallot (TOF) and Ebstein's Anomaly (EA)

Location Details

NCT06693674

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905