BridgeMD
New treatment option for Congenital Heart Disease
Official title Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
ClinicalTrials.gov ID: NCT06668389
What this study is testing
What is SGLT2 inhibitor (Dapagliflozin 10mg)?
SGLT2 inhibitor (Dapagliflozin 10mg) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for congenital heart disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- rTOF
- Aged 18 years or above
- Voluntarily agrees to participate in the clinical trial and provide written informed consent
You likely can't join if
- 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
See the full eligibility criteria
- rTOF
- Aged 18 years or above
- Voluntarily agrees to participate in the clinical trial and provide written informed consent
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.