CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation (NCT06762964) | Clinical Trial Compass
RecruitingPhase 2
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
United States27 participantsStarted 2025-05-16
Plain-language summary
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent prior to any study specific procedures
✓. History of Fontan procedure
✓. Male or female subject
✓. Age ≥ 18
✓. Symptoms of dyspnea (NYHA II-IV) with no non-cardiac or ischemia explanation
✓. Elevated peripheral venous pressure (PVP) at rest or 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
✕. 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)