Department of Cardiology, Herlev-Gentofte University Hospital, Denmark; Faculty of Health and Medical Sciences, Copenhagen University, Denmark.
Department of Cardiology, Odense University Hospital, Denmark; Faculty of Health Sciences, University of Southern Denmark, Denmark.
Am Heart J. 2024 May;271:84-96. doi: 10.1016/j.ahj.2024.02.005. Epub 2024 Feb 15.
Sodium-glucose cotransporter 2 (SGLT2) inhibitors have previously demonstrated cardioprotective properties in patients with type 2 diabetes, suggesting a preventive effect on heart failure (HF). The Empire Prevent trial program investigates the therapeutic potential for HF prevention by evaluating the cardiac, metabolic, and renal effects of the SGLT2 inhibitor empagliflozin in patients with increased risk of developing HF, but without diabetes or established HF.
The Empire Prevent trial program is an investigator-initiated, double-blind, randomized clinical trial program including elderly and obese patients (60-84 years, body mass index >28 kg/m) with at least one manifestation of hypertension, cardiovascular or chronic kidney disease, but no history of diabetes or HF. The aims are to investigate the effects of empagliflozin on 1) physical capacity and left ventricular and atrial structural changes with peak oxygen consumption and left ventricular mass as primary endpoints (Empire Prevent Cardiac), and 2) cardiac-adipose tissue interaction and volume homeostasis with primary endpoints of changes in epicardial adipose tissue and estimated extracellular volume (Empire Prevent Metabolic). At present, 138 of 204 patients have been randomized in the Empire Prevent trial program. Patients are randomized 1:1 to 180 days treatment with empagliflozin 10 mg daily or placebo, while undergoing a comprehensive examination program at baseline and follow-up.
The Empire Prevent trial program will mark the first step towards elucidating the potential of SGLT2 inhibition for HF prevention in an outpatient setting in elderly and obese patients with increased risk of developing HF, but with no history of diabetes or established HF. Furthermore, the Empire Prevent trial program will supplement the larger event-driven trials by providing mechanistic insights to the beneficial effects of SGLT2 inhibition.
Both parts of the trial program have been registered on September 13th 2021 (Clinical Trial Registration numbers: NCT05084235 and NCT05042973) before enrollment of the first patient. All patients will provide oral and written informed consent. The trial is approved by The Regional Committee on Health Research Ethics and the Danish Medicines Agency. Data will be disseminated through scientific meetings and peer-reviewed journals irrespective of outcome.
钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂先前已在 2 型糖尿病患者中显示出心脏保护作用，这表明其对心力衰竭（HF）具有预防作用。Empire Prevent 试验计划通过评估 SGLT2 抑制剂恩格列净对有 HF 发生风险但无糖尿病或已确诊 HF 的患者的心脏、代谢和肾脏影响，来评估其 HF 预防的治疗潜力。
Empire Prevent 试验计划是一项由研究者发起的、双盲、随机临床试验计划，纳入了至少有 1 项高血压、心血管或慢性肾脏病表现但无糖尿病或 HF 病史的老年和肥胖患者（60-84 岁，体重指数>28 kg/m）。目的是研究恩格列净对 1）体力和左心室和心房结构变化的影响，以峰值耗氧量和左心室质量为主要终点（Empire Prevent 心脏），以及 2）心脏脂肪组织相互作用和容量平衡的影响，以心外膜脂肪组织和估计细胞外体积的变化为主要终点（Empire Prevent 代谢）。目前，Empire Prevent 试验计划中已随机分配了 204 例患者中的 138 例。患者以 1:1 的比例随机接受恩格列净 10 mg 每日治疗或安慰剂治疗 180 天，同时在基线和随访时进行全面检查。
Empire Prevent 试验计划将标志着朝着在有 HF 发生风险但无糖尿病或已确诊 HF 病史的老年和肥胖患者的门诊环境中阐明 SGLT2 抑制对 HF 预防潜力的第一步。此外，Empire Prevent 试验计划将通过提供 SGLT2 抑制有益作用的机制见解来补充更大的事件驱动试验。
试验计划的两个部分均于 2021 年 9 月 13 日（临床试验注册号：NCT05084235 和 NCT05042973）在首例患者入组前注册。所有患者均提供口头和书面知情同意。该试验已获得区域卫生研究伦理委员会和丹麦药品管理局的批准。数据将通过科学会议和同行评议期刊进行传播，无论结果如何。
