CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Mayo Clinic

Status and phase: Enrolling; Phase 2

Conditions: Single Ventricle Heart Disease; HFpEF - Heart Failure With Preserved Ejection Fraction; Fontan Circulation

Treatments: Drug: Dapagliflozin tablet; Drug: Placebo Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06762964

24-011044

Details and patient eligibility

About

The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 6 months affects pulmonary capillary wedge pressure (PCWP) at rest and during exercise in adults with failing Fontan circulation.

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 (≥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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups, including a placebo group

Dapagliflozin

Experimental group

Treatment:

Drug: Dapagliflozin tablet

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Tablet