背景:2型糖尿病(T2DM)患者的心肌梗死(MI)和心源性猝死(SCD)的发生率明显高于普通人群。预防致命心律失常的策略往往是不够的,强调需要额外的非侵入性诊断工具。T波异质性(TWH)指数可测量心室复极的变化,并已成为严重室性心律失常的有希望的预测指标。尽管EMPA-REG试验报道了依帕列净降低了心血管死亡率,潜在机制尚不清楚.这项研究通过检查TWH的变化,研究了依帕列净减轻T2DM和冠心病(CHD)患者心脏电不稳定性的潜力。
方法:参与者是患有T2DM和CHD的成年门诊患者,基线时TWH>80µV。他们接受25mg每日剂量的依帕列净,并在基线和4周后进行临床评估,包括心电图(ECG)测量。使用经验证的技术从V4、V5和V6导联计算TWH。主要研究结果是依帕列净给药后TWH的显着变化(p<0.05)。
结果:对6,000份医疗记录的初步审查确定了800名患者进行TWH评估。其中,412显示TWH高于80µV,其中97项完成临床评估,90项符合心血管高风险纳入标准.Empagliflozin依从性超过80%,导致血压显著降低而不影响心率。副作用一般轻微,13.3%的人经历1级低血糖,除了罕见的泌尿和生殖器感染。治疗持续将平均TWH从116降低到103µV(p=0.01)。
结论:EMPATHY-HEART试验初步提示依帕列净能降低T2DM和CHD患者心室复极的异质性。TWH的这种降低可能有助于深入了解先前试验中观察到的心血管死亡率降低背后的机制。可能提供一种治疗途径,以减轻该人群严重心律失常的风险.
背景:NCT:04117763。
BACKGROUND: The incidence of myocardial infarction (MI) and sudden cardiac death (SCD) is significantly higher in individuals with Type 2 Diabetes Mellitus (T2DM) than in the general population. Strategies for the prevention of fatal arrhythmias are often insufficient, highlighting the need for additional non-invasive diagnostic tools. The T-wave heterogeneity (TWH) index measures variations in ventricular repolarization and has emerged as a promising predictor for severe ventricular arrhythmias. Although the EMPA-REG
trial reported reduced cardiovascular mortality with empagliflozin, the underlying mechanisms remain unclear. This
study investigates the potential of empagliflozin in mitigating cardiac electrical instability in patients with T2DM and coronary heart disease (CHD) by examining changes in TWH.
METHODS: Participants were adult outpatients with T2DM and CHD who exhibited TWH > 80 µV at baseline. They received a 25 mg daily dose of empagliflozin and were evaluated clinically including electrocardiogram (ECG) measurements at baseline and after 4 weeks. TWH was computed from leads V4, V5, and V6 using a validated technique. The primary
study outcome was a significant (p < 0.05) change in TWH following empagliflozin administration.
RESULTS: An initial review of 6,000 medical records pinpointed 800 patients for TWH evaluation. Of these, 412 exhibited TWH above 80 µV, with 97 completing clinical assessments and 90 meeting the criteria for high cardiovascular risk enrollment. Empagliflozin adherence exceeded 80%, resulting in notable reductions in blood pressure without affecting heart rate. Side effects were generally mild, with 13.3% experiencing Level 1 hypoglycemia, alongside infrequent urinary and genital infections. The treatment consistently reduced mean TWH from 116 to 103 µV (p = 0.01).
CONCLUSIONS: The EMPATHY-HEART
trial preliminarily suggests that empagliflozin decreases heterogeneity in ventricular repolarization among patients with T2DM and CHD. This reduction in TWH may provide insight into the mechanism behind the decreased cardiovascular mortality observed in previous trials, potentially offering a therapeutic pathway to mitigate the risk of severe arrhythmias in this population.
BACKGROUND: NCT: 04117763.