A Study of Entresto in Tetralogy of Fallot (TOF) and Ebstein's Anomaly (EA)
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
- Tetralogy of Fallot
- Ebstein's Anomaly
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Entresto |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Mayo Clinic in Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
More Details
- NCT ID
- NCT06693674
- Status
- Recruiting
- Sponsor
- Mayo Clinic