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

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

Recruiting
18 years and older
All
Phase 3
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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.

Eligibility

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

Study details
    Tetralogy of Fallot
    Ebstein's Anomaly

NCT06693674

Mayo Clinic

13 January 2025

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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