Dapagliflozin to Improve Exercise and Heart Function in Fontan Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm trial in Fontan patients to see if nightly dapagliflozin can improve exercise tolerance and cardiac performance. Eligible participants from Hong Kong will undergo baseline assessments including medical history, physical exam, vitals, ECG, and laboratory tests, followed by administration of dapagliflozin 5–10 mg daily. Outcomes will focus on exercise capacity and ventricular function, along with safety monitoring. The study uses a pragmatic design due to the small Fontan population and aims to generate preliminary signals of benefit for this unique heart failure group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with a functional single ventricle and who have undergone Fontan procedure
* Adolescents aged ≥ 12 years with body weight ≥30kg and adults

Exclusion Criteria:

* Planned cardiac and/or non-cardiac surgery in 3 months
* Arrhythmias requiring change in therapy in recent 6 months
* Intervention procedure within 6 months prior to enrollment
* Documented structural abnormalities of the Fontan circulation
* Chronic kidney disease stages 4 to 5
* Inability 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 contraindications to SGLT2 inhibitor
* Pregnancy or breast feeding

Where it's running

• Department of Paediatrics and Adolescent Medicine, Hong Kong Children's Hospital
  Hong Kong, Hong Kong Recruiting
• Queen Mary Hospital
  Hong Kong, Hong Kong Not yet recruiting

Study contacts

• Principal investigator: Prof Yiu Fai Cheung — The University of Hong Kong
• Study coordinator: Prof Yiu Fai Cheung
• Email: xfcheung@hku.hk
• Phone: +852-35133888

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.