Comparing Entresto and placebo in patients with Tetralogy of Fallot and Ebstein's Anomaly
Official title: Effect of Sacubitril-Valsartan on Cardiac Structure and Function in Adults With Congenital Heart Disease
Run by Mayo Clinic · NCT06693674 · Data updated 2026-11-12
This study is testing whether the heart medication Entresto can help people with Tetralogy of Fallot and Ebstein's Anomaly feel better and improve their heart function compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | Obinutuzumab |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | February 3, 2025 |
| Main results expected | August 2028 |
| Study ends | August 2028 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT06693674 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 or older diagnosed with Tetralogy of Fallot or Ebstein's Anomaly.
✕Probably not a fit
Patients with severe kidney disease, certain heart conditions, or those on specific disallowed medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effects of Entresto, a heart failure medication, on patients with Tetralogy of Fallot (TOF) and Ebstein's Anomaly (EA). Participants will be randomized to receive either Entresto or a placebo, and the study will assess changes in right ventricular structure and function, biomarkers, and patient-reported outcomes. The research is designed to provide insights into the potential benefits of Entresto for these specific congenital heart conditions.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with Tetralogy of Fallot and Ebstein's Anomaly.
How similar studies have gone: While there may be limited studies specifically on Entresto for these conditions, the use of ARNI medications has shown promise in heart failure management, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Congenital Heart Disease Diagnosis * 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
Where it's running
-
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Alexander Egbe — Mayo Clinic
- Study coordinator: Amanda Wozniak
- Email: Wozniak.Amanda@mayo.edu
- Phone: 507-266-1976
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.