CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation (NCT06762964)
Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (16 items).
Location: Mayo Clinic — Rochester, Minnesota
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria
- Type I diabetes
- Any of the following medications: Insulin or Pramlintide, Sandostatin, Akeega (abiraterone acetate), Growth Hormone (Somatogrogon-GHLA), Lithium, Chloroquine, Hydroxychloroquine, Thioctic acid (alpha lipoic acid), Empagliflozin or Canagliflozin
- Recent hospitalization (\<30 days) or revascularization (\<90 days)
- Significant valvular heart disease (≥moderate stenosis, \>moderate regurgitation)
- Significant Fontan obstruction with resting SVC-IVC gradient \>4 mmHg
- Primary cardiomyopathy (such as amyloid)
- Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator
- Severe anemia (hemoglobin \<9 gm/dl)
- Severe kidney disease (estimated GFR\<30) or liver disease
- Women of childbearing potential not willing to use a medically accepted method of contraception OR who are currently pregnant (confirmed with positive pregnancy test) or breast feeding.
- History of serious hypersensitivity reaction to dapagliflozin
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Mayo Clinic — Rochester, Minnesota
📞 Contact the Study Coordinator
Phone: (507) 266-1976
Email: Wozniak.Amanda@mayo.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.