Fontan Circulation, Single Ventricle Heart Disease, HFpEF - Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
Fontan, HFpEF, SGLT2 inhibitors
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.
Interventions
Patient will take a 10mg tablet of Dapagliflozin once daily for 24 weeks
DRUGPlacebo Tablet
Patient will take 10mg placebo tablet once daily for 24 weeks
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects are eligible to be randomized in the study only if all the following inclusion criteria and none of the
Exclusion criteria
apply: 1. Signed informed consent prior to any study specific procedures 2. History of Fontan procedure 3. Male or female subject 4. Age ≥ 18 5. Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation 6. Undergoing clinically indicated cardiac catheterization 7. Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥20 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary capillary wedge pressure (PCWP) at rest | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary artery pressures with exercise | Baseline, 24 Months | Pulmonary artery pressures will be determined by right heart catheterization with expired gas analysis. Pulmonary artery pressures with expired gas analysis will be performed with exercise. Pulmonary artery pressures will be measured in millimeters of mercury (mmHg). |
| Cardiac output at rest | Baseline, 24 Months | 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 | Baseline, 24 Months | 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 | Baseline, 24 Months | Peak oxygen consumption (VO2) is measured in milliliters of oxygen per minute (mL/min). |
| Right atrial pressure at rest | Baseline, 24 Months | Right atrial pressure at rest will be determined by right heart catheterization with expired gas analysis. Right heart catheterization with expired gas analysis will be performed at rest. Right atrial pressure will be measured in millimeters of mercury (mmHg). |
| Change in blood volume | Baseline, 24 Months | 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). |
| SF-36 quality of life (QOL) | Baseline, 24 Months | 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. |
| Change in fat mass | Baseline, 24 Months | Fat mass will be determined by Dual Energy X-ray Absorptiometry Scan. Fat mass will be measured in kilograms (kg). |
| Change in fat free mass | Baseline, 24 Months | Fat free mass will be determined by Dual Energy X-ray Absorptiometry Scan. Fat free mass will be measured in kilograms (kg). |
| Change in plasma volume | Baseline, 24 Months | 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). |
| Right atrial pressure with exercise | Baseline, 24 Months | Right atrial pressure at rest will be determined by right heart catheterization with expired gas analysis. Right heart catheterization with expired gas analysis will be performed with exercise. Right atrial pressure will be measured in millimeters of mercury (mmHg). |
| Pulmonary artery pressures at rest | Baseline, 24 Months | Pulmonary artery pressures will be determined by right heart catheterization with expired gas analysis. Pulmonary artery pressures with expired gas analysis will be performed at rest. Pulmonary artery pressures will be measured in millimeters of mercury (mmHg). |
Countries
United States
Contacts
Primary ContactAmanda Wozniak
Backup ContactYusef Maarouf
Outcome results
None listed