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.
Signed informed consent prior to any study specific procedures
History of Fontan procedure
Male or female subject
Age ≥ 18
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)
Parallel
Dapagliflozin tablet
DrugPatient will take a 10mg tablet of Dapagliflozin once daily for 12 weeks
Placebo Tablet
DrugPatient will take 10mg placebo tablet once daily for 12 weeks
Peripheral venous pressure (PVP) at rest
Peripheral venous pressure (PVP) at rest will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).
Peripheral venous pressure (PVP) with feet elevated
Peripheral venous pressure (PVP) with feet elevated will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).
Peripheral venous pressure (PVP) at 20W exercise
Peripheral venous pressure (PVP) at 20W exercise will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).
Cardiac output at rest
Cardiac output measures the amount of blood the heart pumps per minute. It is calculated by Cardiac Output= Oxygen Consumption/(Arterial - Venous Oxygen Content Difference). Cardiac output will be measured in liters per minute (L/min).
Cardiac output with exercise
Cardiac output measures the amount of blood the heart pumps per minute. It is calculated by Cardiac Output= Oxygen Consumption/(Arterial - Venous Oxygen Content Difference). Cardiac output will be measured in liters per minute (L/min).
Peak oxygen consumption (VO2) during exercise
Peak oxygen consumption (VO2) is measured in milliliters of oxygen per minute (mL/min).
Change in plasma volume
Plasma volume will be determined by radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique (BVA-100 Blood Volume Analyzer, Daxor Corp, NY). Plasma volume will be measured in milliliters (mL).
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