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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
Patient will take a 10mg tablet of Dapagliflozin once daily for 12 weeks
Patient will take 10mg placebo tablet once daily for 12 weeks
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGPeripheral 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).
Time frame: Baseline, 12 Weeks
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).
Time frame: Baseline, 12 Weeks
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).
Time frame: Baseline, 12 Weeks
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).
Time frame: Baseline, 12 Weeks
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).
Time frame: Baseline, 12 Weeks
Peak oxygen consumption (VO2) during exercise
Peak oxygen consumption (VO2) is measured in milliliters of oxygen per minute (mL/min).
Time frame: Baseline, 12 Weeks
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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).
Time frame: Baseline, 12 Weeks
Change in blood volume
Blood volume will be determined by radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique (BVA-100 Blood Volume Analyzer, Daxor Corp, NY). Blood volume will be measured in milliliters (mL).
Time frame: Baseline, 12 Weeks
SF-36 quality of life (QOL)
SF-36 quality of life (QOL) questionnaire is a 36-question questionnaire that evaluates a patient's quality of life. The score range is from 0-100, with a higher score reflecting a better quality of life.
Time frame: Baseline, 12 Weeks
Change in fat mass
Fat mass will be determined by Dual Energy X-ray Absorptiometry Scan. Fat mass will be measured in kilograms (kg).
Time frame: Baseline, 12 Weeks
Change in fat free mass
Fat free mass will be determined by Dual Energy X-ray Absorptiometry Scan. Fat free mass will be measured in kilograms (kg).
Time frame: Baseline, 12 Weeks