Canagliflozin attenuates CMR-quantified myocardial fibrosis in individuals with type 2 diabetes mellitus at high cardiovascular risk: a randomised open-label controlled trial
Abstract
Aims/hypothesis: We aimed to investigate canagliflozin's effects on myocardial fibrosis, cardiac structure and function, and microcirculation in high-cardiovascular-risk type 2 diabetes mellitus through cardiac magnetic resonance (CMR) quantification, while investigating the cardiovascular protective mechanisms of sodium-glucose cotransporter 2 (SGLT2) inhibitors.
Methods: This open-label parallel RCT recruited 45 high-risk participants (18-75 years) with type 2 diabetes (HbA1c 53.0-91.3 mmol/mol [7.0-10.5%]) and left ventricular ejection fraction (LVEF) >50% from the Endocrinology Outpatient Clinic of Zhongshan Hospital, Fudan University (August 2022 to November 2024). Participants were 1:1 randomised via a computer-generated sequence through the centralised iClinicalStation system (allocation concealed, performed by independent personnel not involved in outcome assessment). They received canagliflozin 100 mg/day (n=23) or sitagliptin 100 mg/day (n=22) for 26 weeks. Consistent with the open-label design, participants and care providers were aware of treatment assignments; however, outcome assessors (radiologists, sonographers) and data analysts remained blinded to group allocation to minimise bias. The primary endpoint was CMR-quantified extracellular volume (ECV) change. Secondary outcomes included ventricular structure and function parameters, for example, left ventricular end-diastolic volume, left ventricular end-diastolic diameter, LVEF, etc. RESULTS: Among 67…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 67 participants or records.
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