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โ† Trials
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The Effect of Dapagliflozin on Exercise and Cardiac Functional Status of Patients After Fontan Procedure

RecruitingPhase 4Ages 12 Years - anyAllThe University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

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-approve

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients with a functional single ventricle and who have undergone Fontan procedure * Adolescents aged โ‰ฅ 12 years with body weight โ‰ฅ30kg and adults Exclusion Criteria: * Planned cardiac and/or non-cardiac surgery in 3 months * Arrhythmias requiring change in therapy in recent 6 months * Intervention procedure within 6 months prior to enrollment * Documented structural abnormalities of the Fontan circulation * Chronic kidney disease stages 4 to 5 * Inability to perform cardiopulmonary test * Recent use of SGLT2 inhibitors within 6 months * Known hypersensitivity to SGLT2 inhibitors * History of diabetic ketoacidosis * Recent symptomatic hypoglycaemia within 6 months * Insulin dependent diabetes mellitus * History of perineum infection * Recent urinary tract infection within 6 months * Recent genital infection within 6 months * Other known contraindications to SGLT2 inhibitor * Pregnancy or breast feeding
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What it tests

  • Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy
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Where

2 sites
Department of Paediatrics and Adolescent Medicine, Hong Kong Children's Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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