Dapagliflozin for Heart Failure
(FonDap Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAri Cedars

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults aged ≥18 with Fontan circulation, stable for the past 6 months, and not expecting to change their medication or undergo any procedures within a month of enrollment. Women must use effective contraception or be non-fertile; men should also use barrier contraception during the study and for three months after.

Inclusion Criteria

You must provide your consent before any procedures related to the study.

No alterations to medical therapy are anticipated within the first month of enrollment.

You must have been clinically stable for the past 6 months (as determined by the Principal Investigator).

+7 more

Participant Groups

The trial is testing if Dapagliflozin can prevent worsening heart failure in adults with Fontan circulation by checking its effects on Fontan pressure and exercise capacity. It includes health assessments, blood tests, physical exams, exercise tests, safety calls, and home blood pressure monitoring over five weeks.

1Treatment groups

Experimental Treatment

Group I: DapagliflozinExperimental Treatment1 Intervention

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

Dapagliflozin is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Forxiga for: