Comparing Entresto and placebo in patients with Tetralogy of Fallot and Ebstein's Anomaly
Effect of Sacubitril-Valsartan on Cardiac Structure and Function in Adults With Congenital Heart Disease
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 |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | Obinutuzumab |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06693674 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 or older diagnosed with Tetralogy of Fallot or Ebstein's Anomaly.
Not a fit: Patients with severe kidney disease, certain heart conditions, or those on specific disallowed medications may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.