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Search / Trial NCT06762964

CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Launched by MAYO CLINIC · Jan 2, 2025

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Fontan H Fp Ef Sglt2 Inhibitors

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

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Luke Burchill, M.B.B.S., Ph.D.

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported