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Influence and mechanism of sodium-glucose cotransporter-2 inhibitors on the cardiac function: study protocol for a
Min-Jia Cao1, Fang-Hong Shi1, Bin-Bin Yu2
1Department of Pharmacy, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Background:
Acute myocardial infarction (AMI) poses a significant threat to cardiovascular diseases (CVDs), leading to a high risk of heart failure (HF) and cardiovascular death. Growing evidence has unveiled the potential of sodium-glucose cotransporter-2 (SGLT2) inhibitors to improve cardiovascular outcomes in patients with CVD regardless of diabetes, but there is limited evidence in AMI patients. Furthermore, it is controversial whether the effects can be ascribed to the amelioration of left ventricular (LV) function, which further complicates the understanding of their underlying mechanism.
Methods:
This study is a prospective, phase IV, open-label, parallel group, single-center trial conducted in a large tertiary teaching hospital in China. A total of 120 patients with AMI and type 2 diabetes mellitus (T2DM) will be included. Those who received SGLT2 inhibitors are considered as the experimental group, and those taking other antidiabetic agents are considered as the control group. The primary outcome is change in LV end-systolic volume index (LVESVi) measured by cardiac magnetic resonance (CMR) imaging from baseline during 1-year follow-up period. Secondary outcomes include other LV parameters such as LV mass, LV volume, and LV ejection fraction (EF); quality of life and functional capacity such as Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and EuroQol-5 dimension (EQ-5D); biomarkers associated with diagnostic parameters of AMI and possible mechanisms on cardiovascular protection, such as creatine kinase, troponin T (TnT) level, troponin I (TnI) level, soluble suppression of tumorigenicity-2 (sST2), galectin-3 (Gal-3), fibroblast growth factor 21 (FGF21), and microRNA (miRNA) level.
Discussion:
This study aims to investigate whether SGLT2 inhibitors could improve LV function by measuring CMR, quality of life, and functional capacity in patients with AMI in real-world settings, providing evidence on the underlying mechanism of SGLT2 inhibitors on cardioprotection.
Clinical Trial Registration:
https://www.chictr.org.cn/showproj.html?proj=173672, identifier ChiCTR2200065792.
Insights
This study investigates if sodium-glucose cotransporter-2 (SGLT2) inhibitors improve heart function after acute myocardial infarction (AMI). It assesses left ventricular function and quality of life in patients with type 2 diabetes mellitus, exploring cardioprotective mechanisms.
Area of Science:
- Cardiology
- Endocrinology
- Pharmacology
Background:
- Acute myocardial infarction (AMI) is a major cause of heart failure and death.
- Sodium-glucose cotransporter-2 (SGLT2) inhibitors show cardiovascular benefits, but their role in AMI patients is unclear.
- The mechanism of SGLT2 inhibitors, particularly their effect on left ventricular (LV) function, requires further investigation.
Purpose of the Study:
- To evaluate the efficacy of SGLT2 inhibitors in improving LV function in AMI patients with type 2 diabetes mellitus (T2DM).
- To assess the impact of SGLT2 inhibitors on quality of life and functional capacity in this patient population.
- To explore the underlying cardioprotective mechanisms of SGLT2 inhibitors in AMI.
Main Methods:
- A prospective, phase IV, open-label, single-center trial involving 120 AMI patients with T2DM.
- Patients receiving SGLT2 inhibitors form the experimental group; others receive standard antidiabetic agents (control group).
- Primary outcome: change in LV end-systolic volume index (LVESVi) via cardiac magnetic resonance (CMR) over 1 year. Secondary outcomes include LV parameters, quality of life (KCCQ-OS, EQ-5D), and biomarkers.
Main Results:
- This section is to be filled after study completion.
Conclusions:
- This section is to be filled after study completion.
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