Actively Recruiting
Effect of Sacubitril-Valsartan on Cardiac Structure and Function
Led by Mayo Clinic · Updated on 2025-10-07
45
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Sacubitril-Valsartan on Cardiac Structure and Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with congenital heart disease
- Age 18 years or older
You will not qualify if you...
- Stage IV chronic kidney disease with creatinine clearance less than 30 ml/min
- High potassium levels (serum potassium greater than 5.2 mmol/l)
- Low blood pressure (systolic blood pressure less than 100 mmHg)
- History of angioedema related to previous ACE or ARB therapy
- Diabetes treated with Aliskiren
- Pregnancy
- Current use of the following drugs: Amifostine, Droperidol, Dantrolene, CYP3A4 inhibitors, Obinutuzumab, Aliskiren, Lithium, Sparsentan, ACE inhibitors, ARBs, or ARNIs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
A
Amanda Wozniak
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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