CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Launched by MAYO CLINIC · Jan 2, 2025

Keywords

ClinConnect Summary

The CAMEO-FONTAN clinical trial is studying a medication called dapagliflozin to see how it affects adults with a specific heart condition known as failing Fontan circulation. This condition often leads to symptoms like shortness of breath during normal activities. The researchers want to find out if taking dapagliflozin for six months can help improve heart function, specifically looking at how pressure in the lungs changes both at rest and during exercise.

To participate in this trial, individuals must be at least 18 years old, have had the Fontan procedure in the past, and experience shortness of breath that isn't caused by other medical issues. They should also be scheduled for a cardiac catheterization, which is a test to check heart function. Participants will receive the medication and will be monitored for six months to see how their heart responds. It's important to note that certain health conditions or medications may prevent someone from being eligible, so discussing these details with a healthcare provider is crucial.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Subjects are eligible to be randomized in the study only if all the following inclusion criteria and none of the exclusion criteria apply:
• • 1. Signed informed consent prior to any study specific procedures
• • 2. History of Fontan procedure
• • 3. Male or female subject
• • 4. Age ≥ 18
• • 5. Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation
• • 6. Undergoing clinically indicated cardiac catheterization
• • 7. Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥25 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 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