The Fontan Dapagliflozin Pilot Study (NCT05741658) | Clinical Trial Compass
By InvitationPhase 4
The Fontan Dapagliflozin Pilot Study
United States29 participantsStarted 2023-11-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of informed consent prior to any study specific procedures
. Female and/or male subjects aged ≥18 years
. Subjects with Fontan circulation (in the opinion of the PI)
. Subjects with clinical stability for 6 months preceding enrollment (in the opinion of the PI)
. Subjects with no planned changes in medical therapy in the 1 months after enrollment
. Subjects with no planned interventional procedures in the 1 months after enrollment
. Negative pregnancy test (urine or serum) for female subjects of childbearing potential.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically studying dapagliflozin in people with Fontan circulation — is my heart condition actually the Fontan physiology this study is designed for, and would I even be a candidate to discuss with the research team?
2The main thing this trial is measuring is peripheral venous pressure at rest — can you explain what that means for my heart health and why lowering it might matter for someone with Fontan circulation?
3Since this is a Phase 4 study, dapagliflozin has already been approved for other conditions like heart failure and diabetes — does that mean more is known about its safety profile than an earlier-phase trial, and are there any risks that would be specific to Fontan patients like me?
4The trial is enrolling by invitation only — how does that process work, and is this something you as my doctor could refer me for, or would I need to be seen at a specific center?
5Before considering this pilot study, are there standard treatments or medications already recommended for managing venous pressure and heart function in Fontan patients that I should try first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peripheral venous pressure (millimeters of mercury) at rest measured by manometry
Timeframe: From baseline at week 0 and to follow up at week 4
. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time the subjects sign consent) and for 3 months after the last dose of Drug A/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
Exclusion criteria
. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
. Previous enrollment or randomisation in the present study
. Participation in another clinical study with an investigational product during the last 6 months
. Pregnancy or breast feeding or desire to become pregnant or breast feed during the study period
. Hospitalization within 6 months prior to enrollment
. Arrhythmia requiring change in therapy within 6 months prior to enrollment
. Interventional procedure of any kind (including cardioversion) within 6 months prior to enrollment
. Difficulty with upper extremity IV placement in the past