Marwick Thomas H, Halabi Amera, Soh Cheng Hwee, Curtin Annie, Sherrif Ashleigh-Georgia, Azad Atro, Wright Leah
Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne, VIC, 3004, Australia.
Western Health, Melbourne, Australia.
Cardiovasc Diabetol. 2025 May 30;24(1):232. doi: 10.1186/s12933-025-02796-4.
Screening for HF may identify asymptomatic abnormalities of LV structure or function, described as stage B heart failure (SBHF) in asymptomatic patients with type 2 diabetes mellitus (T2DM). Sodium-glucose transport protein-2 (SGLT2) inhibitors are associated with reduction of overt HF in T2DM, but the mechanism of their effect in SBHF remains obscure. We sought to assess the response of cardiac function and exercise capacity to dapagliflozin vs placebo in T2DM with stage B HF.
The LEAVE-DM (Limiting the progression of Echocardiographically-Assessed left VEntricular dysfunction in Diabetes Mellitus) trial assessed echocardiography and 6-min walk (6MWD) in 262 people with well-controlled T2DM (age 73 ± 7 years; 159 women). Those with LVD (n = 139) were randomized 1:1 to dapagliflozin 10 mg/day or placebo. Follow-up was undertaken at 6 and 24 months and the primary endpoint was global longitudinal strain (GLS).
Within the randomized group with LV dysfunction, dapagliflozin was associated with reduction of LA volume index (− 2.0 ± 9.0 vs. 0.03 ± 8.6, = 0.002), and average E/e′ (− 0.1 ± 2.4 vs. 0.7 ± 2.4, < 0.001), and improved LA reservoir strain (1.8 ± 4.0 vs. − 0.2 ± 4.0, = 0.02) from baseline to 6 months follow-up. There was an improvement in exercise capacity on dapagliflozin at 6 months follow-up (Δ6MWD 17 ± 46 vs. 2 ± 73 m, = 0.001). However, although abnormal GLS (< 16%) was less common at 6 months follow-up (41% vs. 49%, = 0.03), there was no difference in ΔGLS from baseline to 6 months between dapagliflozin and placebo ( = 0.18). There were no significant differences between 6 and 24 months.
Dapagliflozin showed improvements in diastolic function, atrial function and exercise capacity in in patients with T2DM and SBHF, but no change in GLS. : ACTRN12619001393145 at Australia and New Zealand Clinical Trials registry (https://www.anzctr.org.au/).
心力衰竭（HF）筛查可能会发现左心室结构或功能的无症状异常，在2型糖尿病（T2DM）无症状患者中被描述为B期心力衰竭（SBHF）。钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂与T2DM患者显性HF的减少有关，但其在SBHF中的作用机制仍不清楚。我们试图评估达格列净与安慰剂相比，对T2DM合并B期HF患者心功能和运动能力的影响。
LEAVE-DM（限制糖尿病患者超声心动图评估的左心室功能障碍进展）试验评估了262例T2DM控制良好的患者（年龄73±7岁；159名女性）的超声心动图和6分钟步行距离（6MWD）。左心室功能障碍（LVD）患者（n = 139）按1:1随机分为达格列净10 mg/天或安慰剂组。在6个月和24个月时进行随访，主要终点是整体纵向应变（GLS）。
在随机分组的左心室功能障碍组中，从基线到6个月随访，达格列净与左心房容积指数降低相关（-2.0±9.0 vs. 0.03±8.（此处原文似乎有误，推测为8.6），P = 0.002），平均E/e′降低（-0.1±2.4 vs. 0.7±2.4，P<0.001），左心房储备应变改善（1.8±4.0 vs. -0.2±4.0，P = 0.02）。在6个月随访时，达格列净组的运动能力有所改善（Δ6MWD 17±46 vs. 2±73 m，P = 0.001）。然而，尽管在6个月随访时异常GLS（<16%）不太常见（41% vs. 49%，P = 0.03），但达格列净组与安慰剂组从基线到6个月的ΔGLS没有差异（P = 0.18）。6个月和24个月之间没有显著差异。
达格列净在T2DM合并SBHF患者中显示出舒张功能、心房功能和运动能力的改善，但GLS没有变化。在澳大利亚和新西兰临床试验注册中心的注册号为ACTRN12619001393145（https://www.anzctr.org.au/）。
