Effect of Sacubitril-Valsartan on Cardiac Structure and Function
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Congenital Heart Disease
In brief
The purpose of this study is to compare changes in cardiac structure and function, biomarkers, and patient reported outcomes between adults with congenital heart disease (ACHD) randomized to angiotensin receptor-neprilysin inhibitor (ARNI) therapy vs placebo.
Key facts
- Study ID
- NCT06693674
- Run by
- Mayo Clinic
- People needed
- 45
- Starts
- 2025-02-03
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-10-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Congenital Heart Disease Diagnosis
- Age 18 or Older
You may not qualify if…
- 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 is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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