Could a diabetes pill ease heart failure in fontan patients?
NCT ID NCT05741658
First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times
Summary
This study tests whether a daily pill called dapagliflozin can help adults with Fontan circulation, a heart condition from birth. Researchers want to see if it lowers pressure in the veins and improves exercise ability. About 29 adults will take the drug for 4 weeks and have checkups including blood tests and exercise tests.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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29 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: For inclusion in the study subjects should fulfil the following criteria based on local regulations: 1. Provision of informed consent prior to any study specific procedures 2. Female and/or male subjects aged ≥18 years 3. Subjects with Fontan circulation (in the opinion of the PI) 4. Subjects with clinical stability for 6 months preceding enrollment (in the opinion of the PI) 5. Subjects with no planned changes in medical therapy in the 1 months after enrollment 6. Subjects with no planned interventional procedures in the 1 months after enrollment 7. Negative pregnancy test (urine or serum) for female subjects of childbearing potential. 8. 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. 9. Male subjects must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) 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 a partner. 10. Subjects who are blood donors should not donate blood during the study and for 3 months following the subject's last dose of dapagliflozin. Exclusion Criteria: Subjects should not enter the study if any of the following exclusion criteria are fulfilled: 1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site) 2. Previous enrollment or randomisation in the present study 3. Participation in another clinical study with an investigational product during the last 6 months 4. Pregnancy or breast feeding or desire to become pregnant or breast feed during the study period 5. Hospitalization within 6 months prior to enrollment 6. Arrhythmia requiring change in therapy within 6 months prior to enrollment 7. Interventional procedure of any kind (including cardioversion) within 6 months prior to enrollment 8. Difficulty with upper extremity IV placement in the past 9. Known obstruction anywhere within the venous circulation including at the level of the Glenn or Fontan anastomosis or within the pulmonary vasculature. 10. Symptomatic hypotension or systemic systolic blood pressure of \<95 millimeters of mercury (mmHg) 11. Estimated glomerular filtration rate of \<25ml per minute per 1.73m2 body surface area as assessed by Modification of Diet in Renal Disease (MDRD) calculation 12. Prior use of SGLT2 inhibitors with intolerable side effects 13. Type 1 diabetes 14. Inability to comply with the study protocol 15. Lack of English-proficiency 16. History of hypersensitivity to SGLT2 inhibitors 17. Severe hepatic impairment defined as a Model for End-stage Liver Disease (MELD) XI score of \>10
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
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Other studies related to the condition(s) this trial covers.
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