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达格列净对慢性肾脏病患者超声心动图心脏结构和功能指标的影响:DECODE-CKD 试验。

Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease: The DECODE-CKD Trial.

机构信息

Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark.

Department of Nephrology, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark.

出版信息

Kidney360. 2023 Feb 1;4(2):143-149. doi: 10.34067/KID.0006982022. Epub 2022 Dec 18.

Abstract

KEY POINTS

SGLT2 inhibitors (SGLT2i) exert cardioprotective effects in patients with CKD through unknown mechanisms. DECODE-CKD is the first randomized controlled trial (RCT) to evaluate the effects of SGLT2i on cardiac structure and function in patients with CKD.

BACKGROUND

SGLT2 inhibitors, originally developed as glucose-lowering agents for treatment of type 2 diabetes, have been shown to have cardio- and kidney-protective effects among CKD patients with and without diabetes. However, the mechanisms remain largely unknown.

METHODS

Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease (DECODE-CKD) is an investigator-initiated, prospective, single-center, randomized, placebo-controlled trial evaluating the effects of 6 months of treatment with 10 mg of dapagliflozin compared with placebo on cardiac structure and function in 222 adults with CKD.

RESULTS

The primary objective was to assess whether dapagliflozin improves left ventricular mass index. Secondary and exploratory end points include changes in cardiac and kidney markers, quality of life, depressive symptoms, and cognitive function.

CONCLUSIONS

This is the first study to address the effects of SGLT2 inhibitors on cardiac structure and function in patients with CKD. The results will provide valuable insights into the mechanisms underlying the cardioprotective benefits of SGLT2 inhibitors in patients with CKD.

CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER

NCT05359263

摘要

要点

SGLT2 抑制剂(SGLT2i)通过未知机制对 CKD 患者发挥心脏保护作用。DECODE-CKD 是首个评估 SGLT2i 对 CKD 患者心脏结构和功能影响的随机对照试验(RCT)。

背景

SGLT2 抑制剂最初是作为治疗 2 型糖尿病的降糖药物开发的,已被证明对有或没有糖尿病的 CKD 患者具有心脏和肾脏保护作用。然而,其机制在很大程度上仍不清楚。

方法

达格列净对慢性肾脏病患者心脏结构和功能的超声心动图评估(DECODE-CKD)是一项由研究者发起的、前瞻性的、单中心的、随机的、安慰剂对照试验,评估了 6 个月的 10mg 达格列净治疗与安慰剂相比对 222 名 CKD 成年患者心脏结构和功能的影响。

结果

主要目的是评估达格列净是否改善左心室质量指数。次要和探索性终点包括心脏和肾脏标志物、生活质量、抑郁症状和认知功能的变化。

结论

这是第一项研究 SGLT2 抑制剂对 CKD 患者心脏结构和功能影响的研究。研究结果将为 SGLT2 抑制剂在 CKD 患者中的心脏保护作用的机制提供有价值的见解。

临床试验注册号

NCT05359263

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b6ab/10103327/2d11ff0709dc/kidney360-4-143-g001.jpg

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