Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study
Overview
- Phase
- Phase 2
- Intervention
- Dapagliflozin tablet
- Conditions
- Not specified
- Sponsor
- Mayo Clinic
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Pulmonary capillary wedge pressure (PCWP) at rest
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 6 months affects pulmonary capillary wedge pressure (PCWP) at rest and during exercise in adults with failing Fontan circulation.
Investigators
Luke J. Burchill
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dapagliflozin
Intervention: Dapagliflozin tablet
Placebo
Intervention: Placebo Tablet
Outcomes
Primary Outcomes
Pulmonary capillary wedge pressure (PCWP) at rest
Time Frame: Baseline, 24 Months
Pulmonary Capillary Wedge pressure will be determined by right heart catheterization with expired gas analysis. Right heart catheterization with expired gas analysis will be performed at rest. Pulmonary Capillary Wedge Pressure is measured in millimeters of mercury (mmHg).
Pulmonary capillary wedge pressure with feet elevated
Time Frame: Baseline, 24 Months
Pulmonary Capillary Wedge pressure will be determined by right heart catheterization with expired gas analysis. Right heart catheterization with expired gas analysis will be performed with feet elevated. Pulmonary Capillary Wedge Pressure is measured in millimeters of mercury (mmHg).
Pulmonary capillary wedge pressure at 20W exercise
Time Frame: Baseline, 24 Months
Pulmonary Capillary Wedge pressure will be determined by right heart catheterization with expired gas analysis. Right heart catheterization with expired gas analysis will be performed at 20W exercise. Pulmonary Capillary Wedge Pressure is measured in millimeters of mercury (mmHg).
Secondary Outcomes
- Right atrial pressure at rest(Baseline, 24 Months)
- Right atrial pressure with exercise(Baseline, 24 Months)
- Pulmonary artery pressures at rest(Baseline, 24 Months)
- Pulmonary artery pressures with exercise(Baseline, 24 Months)
- Cardiac output at rest(Baseline, 24 Months)
- Cardiac output with exercise(Baseline, 24 Months)
- Peak oxygen consumption (VO2) during exercise(Baseline, 24 Months)
- Change in plasma volume(Baseline, 24 Months)
- Change in blood volume(Baseline, 24 Months)
- SF-36 quality of life (QOL)(Baseline, 24 Months)
- Change in fat mass(Baseline, 24 Months)
- Change in fat free mass(Baseline, 24 Months)