Tests dapagliflozin in adults with a failing Fontan heart circulation
Tests dapagliflozin against a placebo pill in adults with failing Fontan circulation.
Plain-language title generated from the registry record
Registry title: CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
Key facts
- Where
- Rochester, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Mayo ClinicRochester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mayo Clinic
- Trial code
- NCT06762964
- Record updated
- 6 May 2026
- Original description
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.Read full original descriptionShow less
Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study
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.
Inclusion: Signed informed consent prior to any study specific procedures; History of Fontan procedure; Male or female subject; Age ≥ 18; Symptoms of dyspnea (NYHA II-IV) with no non-cardiac or ischemia explanation; Elevated peripheral venous pressure (PVP) at rest or during exercise (≥20 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized.
Exclusion: 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; Type I diabetes; Significant valvular heart disease (≥moderate stenosis, >moderate regurgitation); Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator; History of serious hypersensitivity reaction to dapagliflozin; Subjects with severe liver disease with history of decompensation including ascites or encephalopathy or variceal bleeding; Single ventricle heart disease without Fontan palliation; Those with a history of Fontan takedown; Severe anemia (hemoglobin <9 gm/dl); Severe kidney disease (estimated GFR<30) or liver disease; Recent hospitalization (<30 days) or revascularization (<90 days); Significant Fontan obstruction with resting SVC-IVC gradient >4 mmHg; Primary cardiomyopathy (such as amyloid); 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; Subjects on dialysis.