RecruitingPhase 2NCT06762964

CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study


Sponsor

Mayo Clinic

Enrollment

27 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether dapagliflozin — a drug originally developed for diabetes and heart failure — can help adults who have a Fontan circulation. The Fontan procedure is a heart surgery done in childhood for people born with a single functioning heart ventricle; over time, these patients can develop heart failure-like symptoms. **You may be eligible if...** - You are 18 or older - You have had the Fontan procedure - You experience shortness of breath with activity (NYHA class II–III) - During a cardiac catheterization procedure, your pulmonary pressure during exercise is elevated (≥20 mmHg) **You may NOT be eligible if...** - You have type 1 diabetes - You are taking insulin or certain other diabetes/heart medications - You have severely reduced kidney function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapagliflozin tablet

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


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT06762964


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