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Study identifier: NCT06668389 Synced from ClinicalTrials.gov · July 28, 2026
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Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial

Condition: Congenital Heart Disease · Repaired Tetralogy of Fallot (rTOF) · Pulmonary Regurgitation  ·  Sponsor: The University of Hong Kong

PhasePhase 4
Planned participants106
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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. One sequalae that nearly all rTOF patients develop during their lifetime is significant pulmonary regurgitation. Pulmonary regurgitation causes progressive right ventricular dilatation and systolic dysfunction, which in turn impairs cardio-pulmonary function and overall survival. There is currently no pharmacological therapy proven to improve cardio-pulmonary function in rTOF patients. In a double-blind, placebo controlled, randomized controlled trial involving 33 rTOF patients, the use of beta-adrenergic receptor blocker Bisoprolol failed to improve maximal oxygen uptake (VO2 max) in the treatment group. Furthermore, there was no significant change in dimension of right ventricle on cardiac imaging, or heart failure biomarkers including brain natriuretic peptide (BNP) and atrial natriuretic peptide (ANP). In the APPROPRIATE trial involving 64 patients, angiotensin-converting-enzyme inhibitor (ACEI) Ramipril similarly failed to improve VO2 max despite an improved right ventricular long-axis shortening. In REDEFINE trial, 95 rTOF patients were randomized in to receive angiotensin receptor blocker (ARB) Losartan and control. At the end of study, there was no signi…

This description comes directly from the study's public registry record.

Talk to the study team

Chun Ka Dr Wong, Clinical Assistant Professor  ·  +852-22553111  ·  wongeck@hku.hk

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Locations (1)

Department of Medicine, Queen Mary HospitalHong Kong, Hong KongRecruiting

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Source record: clinicaltrials.gov/study/NCT06668389