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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Entresto
  • Drug: Entresto Pill
    Patients will take a 24/26 mg dose orally, twice daily, for weeks 1 and 2, 49/51 mg orally, twice daily, for weeks 3 and 4, and 97/103 mg orally twice daily, for the remaining 48 weeks (total duration: 52 weeks).
Placebo Comparator
Placebo
  • Other: Placebo
    Patients taking placebo tablets will take 1 tablet orally, twice daily

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Amanda Wozniak
507-266-1976
Wozniak.Amanda@mayo.edu

More Details

NCT ID
NCT06693674
Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Amanda Wozniak
507-266-1976
Wozniak.Amanda@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center