Actively Recruiting
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
Led by Mayo Clinic · Updated on 2026-05-06
27
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.
CONDITIONS
Official Title
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to any study specific procedures
- History of Fontan procedure
- Male or female subject
- Age 18 years or older
- Symptoms of dyspnea (NYHA II-IV) without non-cardiac or ischemia explanation
- Elevated peripheral venous pressure (≥20 mmHg) at rest or during exercise confirmed at Visit 1
You will not qualify if you...
- Type I diabetes
- Use of insulin, pramlintide, sandostatin, abiraterone acetate, growth hormone (Somatogrogon-GHLA), lithium, chloroquine, hydroxychloroquine, thioctic acid, empagliflozin, or canagliflozin
- Recent hospitalization within 30 days or revascularization within 90 days
- Significant valvular heart disease (moderate or worse stenosis, more than moderate regurgitation)
- Significant Fontan obstruction with resting SVC-IVC gradient greater than 4 mmHg
- Primary cardiomyopathy such as amyloid
- Dyspnea due to primary lung disease or myocardial ischemia as judged by investigator
- Severe anemia (hemoglobin less than 9 gm/dl)
- Severe kidney disease (estimated GFR less than 30) or liver disease
- Women of childbearing potential not using contraception, pregnant, or breastfeeding
- History of serious hypersensitivity to dapagliflozin
- On dialysis
- Severe liver disease with history of decompensation including ascites, encephalopathy, or variceal bleeding
- Single ventricle heart disease without Fontan palliation
- History of Fontan takedown
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
A
Amanda Wozniak
CONTACT
Y
Yusef Maarouf
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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