Condition: Fontan · Heart Failure · Dapagliflozin · Sponsor: The University of Hong Kong
While the Fontan operation improves survival for patients with a functional single ventricle, complications like heart failure remain prevalent during follow-up, causing frequent hospitalizations and reduced quality of life. Currently, there are no evidence-based heart failure therapies or guidelines for patients with Fontan palliation. There is growing interest in using sodium-glucose cotransporter 2 inhibitors (SGLT2i) to optimize cardiac conditions in this group. SGLT2i's observed benefits relate to protective effects on cardiac energy metabolism, renal function, sympathetic activation, inflammation, oxidative stress, erythropoiesis, and vascular function. Therefore, SGLT2i may represent a new therapeutic agent to improve exercise capacity and ventricular function in patients with Fontan circulation. This prospective, open-label, single-arm clinical trial investigates the FDA-approved drug dapagliflozin. An open-label design is utilized due to the relatively small cohort of patients with complex underlying hearts. The trial will be conducted at Hong Kong Children's Hospital (the sole pediatric cardiology center in Hong Kong) and Queen Mary Hospital (the largest tertiary referral center for adult congenital heart patients). The total study duration is 2 years. Subjects will participate for 3 months, receiving oral dapagliflozin 10mg once daily. The primary endpoint is VO2 max (maximum rate of oxygen consumption) during cardiopulmonary exercise testing at 3 months. Seconda…
This description comes directly from the study's public registry record.
Prof Yiu Fai Cheung · +852-35133888 · xfcheung@hku.hk
Always discuss trial participation with your own doctor first.
| Department of Paediatrics and Adolescent Medicine, Hong Kong Children's Hospital | Hong Kong, Hong Kong | Recruiting |
| Queen Mary Hospital | Hong Kong, Hong Kong | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07482943