Effect of Sacubitril-Valsartan on Cardiac Structure and Function
Recruiting
Phase 3
Interventional Study
Congenital Heart Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 45 (estimated)
- Sponsor
- Mayo Clinic · Other
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About This Trial
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.
Trial Locations
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Eligibility 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,
* Histo…
Contacts