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The Fontan Dapagliflozin Pilot Study

NCT05741658 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dapagliflozin 10mg Tab

Participants will take one Dapagliflozin 10mg tablet once per day for 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Ari Cedars · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2026-04-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05741658 on ClinicalTrials.gov