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Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial

RecruitingPhase 4Ages 18 Years - anyAllThe University of Hong Kong
NCT06668389 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease. With advances in open-heart surgical repair techniques and medical therapies, there is a significant increase in patients with rTOF surviving till late adulthood. One sequalae that nearly all rTOF patients develop during their lifetime is significant pulmonary regurgitation. Pulmonary regurgitation causes progressive right ventricular dilatation and systolic dysfunction, which in turn impairs cardio-pulmonary function and overall survival. There is currently no pharmacological therapy proven to improve cardio-pulmonary function in rTOF patients. In a double-blind, placebo controlled, randomized controlled trial involving 33 rTOF patients, the use of beta-adrenergic receptor blocker Bisoprolol failed to improve maximal oxygen uptake (

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📋 Eligibility rules (as published)
Inclusion Criteria: * rTOF * Aged 18 years or above * Voluntarily agrees to participate in the clinical trial and provide written informed consent Exclusion Criteria: * Heart failure with reduced ejection fraction (HFrEF) with LVEF \< 40% * Planned cardiac and/or non-cardiac surgery in 3 months * Chronic kidney disease stages 4 to 5 * Unable 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 contraindication to SGLT2 inhibitor * Pregnancy or breast feeding
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What it tests

  • SGLT2 inhibitor (Dapagliflozin 10mg)
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Where

1 site
Department of Medicine, Queen Mary Hospital
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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