CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Phase 2

Recruiting

• Conditions: Fontan Circulation; Single Ventricle Heart Disease; HFpEF - Heart Failure With Preserved Ejection Fraction
• Interventions: Drug: Dapagliflozin tablet; Drug: Placebo Tablet

• Registration Number: NCT06762964
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-08
• Status Verified: 2025-05
• Study Start: 2025-05-16
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin	Dapagliflozin tablet	-
Placebo	Placebo Tablet	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).
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).
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).
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).

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States