RecruitingPhase 2NCT06762964

CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study

Sponsor

Mayo Clinic

Enrollment

27 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Signed informed consent prior to any study specific procedures
History of Fontan procedure
Male or female subject
Age ≥ 18
Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation
Undergoing clinically indicated cardiac catheterization
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 Criteria15

Type I diabetes
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
Recent hospitalization (\<30 days) or revascularization (\<90 days)
Significant valvular heart disease (≥moderate stenosis, \>moderate regurgitation)
Significant Fontan obstruction with resting SVC-IVC gradient \>4 mmHg
Primary cardiomyopathy (such as amyloid)
Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator
Severe anemia (hemoglobin \<9 gm/dl)
Severe kidney disease (estimated GFR\<30) or liver disease
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.
History of serious hypersensitivity reaction to dapagliflozin
Subjects on dialysis
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