Actively Recruiting
Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study
Led by Mayo Clinic · Updated on 2026-05-06
27
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with failing Fontan circulation to see if treatment with the drug dapagliflozin over 12 weeks can change peripheral venous pressure at rest and during exercise. This phase II, double-blind study aims to better understand cardiac and metabolic effects in people who have undergone the Fontan procedure and experience symptoms like shortness of breath. Participants will be randomly assigned to take either a 10mg dapagliflozin tablet or a placebo once daily for 12 weeks. The study compares these two groups without knowing which treatment each person receives. The focus is on measuring peripheral venous pressure at rest, with feet elevated, and during exercise at both the start and end of the treatment period. During the study, participants will have their cardiac output, peak oxygen consumption during exercise, blood and plasma volume, body fat and lean mass, and quality of life assessed at the beginning and after 12 weeks. Safety and heart function will be monitored throughout. The total participation time includes baseline assessments, 12 weeks of treatment, and follow-up evaluations up to February 2027.
CONDITIONS
Brief Title
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- History of Fontan procedure
- Male or female adult aged 18 years or older
- Symptoms of shortness of breath (NYHA II-IV) without non-cardiac or ischemic cause
- Elevated peripheral venous pressure (≥20 mmHg) at rest or during exercise confirmed at screening
You will not qualify if you...
- Type I diabetes
- Use of insulin, pramlintide, Sandostatin, Akeega, growth hormone therapies, lithium, chloroquine, hydroxychloroquine, thioctic acid, empagliflozin, or canagliflozin
- Hospitalization within 30 days or heart revascularization within 90 days
- Significant valvular heart disease (≥moderate stenosis or >moderate regurgitation)
- Significant Fontan obstruction with resting SVC-IVC gradient >4 mmHg
- Primary cardiomyopathy such as amyloid
- Shortness of breath caused by lung disease or myocardial ischemia
- Severe anemia (hemoglobin <9 gm/dl)
- Severe kidney disease (eGFR <30) or liver disease
- Women of childbearing potential not using contraception, pregnant, or breastfeeding
- History of serious allergic reaction to dapagliflozin
- On dialysis
- Severe liver disease with complications like ascites, encephalopathy, or variceal bleeding
- Single ventricle heart disease without Fontan palliation
- History of Fontan takedown
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take a daily tablet of either Dapagliflozin or placebo for 12 weeks.
Baseline visit and follow-up visits during treatment
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
A
Amanda Wozniak
Y
Yusef Maarouf
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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