The Fontan Dapagliflozin Pilot Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
Johns Hopkins University
Study ID
NCT05741658
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 8, 2023
Status verified
Jun 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Dapagliflozin
    4-week, Daily Oral Use of Dapagliflozin 10mg Tablet in Adults with Fontan Circulation

Primary Outcome Measure

Peripheral venous pressure (millimeters of mercury) at rest measured by manometry [ Time Frame: From baseline at week 0 and to follow up at week 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-

Find similar trials in Los Angeles, CA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Ronald Reagan UCLA Medical Center· Los Angeles, CA

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