Overview

The Fontan Dapagliflozin Pilot Study

Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to study if an investigational study drug called Dapagliflozin could prevent heart failure from getting worse in adults with Fontan circulation. The main questions it aims to answer are: 1. Does Dapagliflozin decrease Fontan pressure? 2. Does Dapagliflozin improve exercise capacity and heart failure symptoms? Participants will have 4 study visits and 2 follow-up phone calls. The total duration of participation in the study will be up to 5 weeks from the time of screening to the completion of the final safety evaluation. Study procedures include the collection of study-related health information and blood samples, physical examination, exercise testing, total body water assessment, blood laboratory testing, health status survey, safety evaluation phone calls, and home blood pressure monitoring.
Phase:
Phase 4
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
AstraZeneca
Brett Boyer Foundation
University of California, Los Angeles
Treatments:
Dapagliflozin