Using Dapagliflozin to Improve Heart and Lung Function in Patients with Repaired Tetralogy of Fallot
Official title: Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial (STEPS Trial)
Run by The University of Hong Kong · NCT06668389 · Data updated 2026-11-12
This study is testing if the medication Dapagliflozin can help improve heart and lung function in adults who have had surgery for Tetralogy of Fallot.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 106 (estimated) |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Status | Recruiting |
| Started | May 12, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT06668389 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have a diagnosis of repaired Tetralogy of Fallot.
✕Probably not a fit
Patients with heart failure with reduced ejection fraction, chronic kidney disease stages 4 to 5, or those with recent infections or contraindications to SGLT2 inhibitors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of the sodium-glucose cotransporter 2 inhibitor, Dapagliflozin, on patients with repaired Tetralogy of Fallot (rTOF) to enhance their cardio-pulmonary status. Participants aged 18 and older will be recruited from Queen Mary Hospital in Hong Kong and undergo a series of assessments including medical history reviews, physical examinations, and various tests to evaluate their health. The study will utilize a double-blind, placebo-controlled design to ensure unbiased results, with randomization occurring on the day of recruitment. The goal is to determine if Dapagliflozin can improve cardio-pulmonary function in this patient population, which currently lacks effective pharmacological therapies.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the cardio-pulmonary function and overall quality of life for patients with repaired Tetralogy of Fallot.
How similar studies have gone: While previous studies have explored treatments for rTOF, this specific approach using SGLT2 inhibitors is novel and has not been extensively tested in this patient population.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Department of Medicine, Queen Mary Hospital
Hong Kong, Hong Kong Recruiting
Study contacts
- Principal investigator: Chun-Ka Dr Wong, Clinical Assistant Professor — The University of Hong Kong/ Department of Medicine, Queen Mary Hospital
- Study coordinator: Chun Ka Dr Wong, Clinical Assistant Professor
- Email: wongeck@hku.hk
- Phone: +852-22553111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.