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

Launched by THE UNIVERSITY OF HONG KONG · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called Dapagliflozin, which belongs to a group of drugs known as SGLT2 inhibitors, can improve heart and lung function in patients with a condition called repaired Tetralogy of Fallot (rTOF). rTOF is a type of congenital heart disease that affects blood flow in the heart and can lead to issues like pulmonary regurgitation, which can harm the heart's ability to pump effectively. While previous treatments have not shown significant benefits, SGLT2 inhibitors have shown promise in improving heart function in other patients. The goal of this trial is to find out if Dapagliflozin can help rTOF patients as well.

To be eligible for this trial, participants must be at least 18 years old and have a diagnosis of rTOF. They should also agree to participate voluntarily. However, individuals with certain health conditions, like severe heart failure or chronic kidney disease, or those who have recently had specific medical issues, will not be able to join. Participants will undergo tests to evaluate their heart and lung function and will receive either the medication or a placebo (a non-active pill) to see how it affects their health over time. This study is important because it could lead to new treatment options for rTOF patients who currently have limited choices to improve their heart and lung health.

Gender

ALL

Eligibility criteria

• 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