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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin tablet | Drug | Patient will take a 10mg tablet of Dapagliflozin once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | Baseline, 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 12 Weeks |
| Cardiac output with exercise |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Wozniak | Contact | 507-266-1976 | Wozniak.Amanda@mayo.edu | |
| Yusef Maarouf | Contact | 507-422-5755 | Maarouf.Yusef@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Luke Burchill, M.B.B.S., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Placebo Tablet | Drug | Patient will take 10mg placebo tablet once daily for 12 weeks |
|
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). |
| Baseline, 12 Weeks |
| Peak oxygen consumption (VO2) during exercise | Peak oxygen consumption (VO2) is measured in milliliters of oxygen per minute (mL/min). | Baseline, 12 Weeks |
| 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). | 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). | 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. | 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). | 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). | Baseline, 12 Weeks |