Using Dapagliflozin to Improve Heart and Lung Function in Patients with Repaired Tetralogy of Fallot
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial (STEPS Trial)
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 |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06668389 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a diagnosis of repaired Tetralogy of Fallot.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hong Kong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.