CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

Signed informed consent prior to any study specific procedures

History of Fontan procedure

Male or female subject

Age ≥ 18

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Dapagliflozin tablet
  • Placebo Tablet

Treatment groups

27 Participants
are divided into 2 treatment groups

Sponsors and collaborators