ConditionsFontan CirculationSingle Ventricle Heart DiseaseHFpEF - Heart Failure With Preserved Ejection Fraction
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 groupsSponsors and collaborators
Source ClinicalTrials.gov