CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Exclusion Criteria

• •1. Type I diabetes
• •2. 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
• •3. Recent hospitalization (\<30 days) or revascularization (\<90 days)
• •4. Significant valvular heart disease (≥moderate stenosis, \>moderate regurgitation)
• •5. Significant Fontan obstruction with resting SVC-IVC gradient \>4 mmHg
• •6. Primary cardiomyopathy (such as amyloid)
• •7. Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator
• •8. Severe anemia (hemoglobin \<9 gm/dl)
• •9. Severe kidney disease (estimated GFR\<30) or liver disease
• •10. 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.
• •11. History of serious hypersensitivity reaction to dapagliflozin
• •12. Subjects on dialysis
• •13. Subjects with severe liver disease with history of decompensation including ascites or encephalopathy or variceal bleeding
• •14. Single ventricle heart disease without Fontan palliation
• •15. Those with a history of Fontan takedown