Effects of SGLT2 inhibitors on cardiac autonomic activity and ventricular remodeling in patients with acute myocardial infarction: study protocol for a clinical trial
Abstract
Background: Sodium-glucose co-transporter 2 inhibitors (SGLT2-I) exhibit significant cardiovascular protective effects in patients with acute myocardial infarction (AMI) complicated with type 2 diabetes mellitus (T2DM), mainly through enhancing cardiac function and reducing malignant arrhythmias. However, limited evidence exists regarding their efficacy in non-diabetic AMI patients. Moreover, the relationship between these benefits and improvements in cardiac autonomic function and left ventricular remodeling remains contentious, hindering a comprehensive understanding of their mechanisms of action. This study aims to fill this knowledge gap regarding dapagliflozin's effects on cardiac autonomic activity and ventricular remodeling in AMI patients.
Methods: This study is a prospective, randomized, open-label, assessor-blinded, single-center trial in AMI patients in China. A total of 110 participants will be randomly allocated in a 1:1 ratio to either receive standardized treatment alone or receive standardized treatment along with 10 mg of dapagliflozin taken once daily. The primary endpoint is the change from the baseline to 24 weeks in heart rate variability (HRV) and deceleration capacity (DC) measured by 24-h ambulatory Holter monitoring. Secondary endpoints include changes in the left ventricular remodeling index (a relative change of LV end-diastolic volume, LVRI) as measured from baseline, along with the incidence of major adverse cardiovascular events throughout the…
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: 110 participants or records.
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