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多中心临床试验的理论基础和设计:日本血管紧张素受体阻滞剂选择工作组(阿齐沙坦与坎地沙坦)对射血分数保留心力衰竭患者舒张功能影响的研究:J-TASTE 试验。

Rationale and Design of the Multicenter Trial on Japan Working Group on the Effects of Angiotensin Receptor Blockers Selection (Azilsartan vs. Candesartan) on Diastolic Function in the Patients Suffering from Heart Failure with Preserved Ejection Fraction: J-TASTE Trial.

机构信息

Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, 565-8565, Japan.

Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Center, Suita, 565-8565, Japan.

出版信息

Cardiovasc Drugs Ther. 2018 Aug;32(4):381-388. doi: 10.1007/s10557-018-6799-5.

DOI:10.1007/s10557-018-6799-5
PMID:29974299
Abstract

BACKGROUND

Previous studies suggest that the pathophysiology of heart failure with preserved ejection fraction (HFpEF) is characterized not only by high ventricular stiffness, but also by vascular stiffness. Azilsartan has higher vascular affinity compared with other angiotensin II receptor blockers (ARBs), which were proven to have no beneficial effects on clinical outcomes in patients with HFpEF in earlier clinical trials. We aimed to test the hypothesis that azilsartan may improve left ventricular diastolic function in HFpEF patients with hypertension in this trial.

METHODS

The Effects of Angiotensin Receptor Blockers on Diastolic Function in Patients Suffering from Heart Failure with Preserved Ejection Fraction: J-TASTE trial is a multicenter, randomized, open-labeled, and assessor(s)-blinded, active controlled using candesartan, parallel-group clinical trial, to compare changes in left ventricular (LV) diastolic dysfunction between HFpEF patients with hypertension who have received candesartan or azilsartan for 48 weeks. The primary endpoint is the change in early diastolic wave height/early diastolic mitral annulus velocity (E/e') assessed by echocardiography from the baseline to the end of the study (48 weeks). A total of 190 patients will be recruited into the study.

CONCLUSIONS

The design of the J-TASTE trial will provide data on whether differences between the effects of the two tested drugs on LV diastolic function exist in HFpEF patients with hypertension and will improve understanding of the pathophysiological role of vascular stiffness on diastolic function.

摘要

背景

既往研究表明,射血分数保留的心力衰竭(HFpEF)的病理生理学不仅表现为心室僵硬度增加,还表现为血管僵硬度增加。与其他血管紧张素 II 受体阻滞剂(ARB)相比,阿齐沙坦对血管的亲和力更高,而在之前的临床试验中,ARB 类药物并未显示出对 HFpEF 患者的临床结局有获益。我们旨在通过本试验检验阿齐沙坦可能改善高血压合并 HFpEF 患者左心室舒张功能的假设。

方法

血管紧张素受体阻滞剂对射血分数保留心力衰竭患者舒张功能的影响:J-TASTE 试验是一项多中心、随机、开放标签、评估者设盲、活性对照(坎地沙坦)、平行组临床试验,旨在比较高血压合并 HFpEF 患者接受坎地沙坦或阿齐沙坦治疗 48 周后左心室(LV)舒张功能的变化。主要终点是超声心动图评估的从基线到研究结束(48 周)时舒张早期波峰高度/舒张早期二尖瓣环速度(E/e')的变化。该研究将纳入 190 例患者。

结论

J-TASTE 试验的设计将提供关于两种受试药物对高血压合并 HFpEF 患者左心室舒张功能影响是否存在差异的数据,并将提高对血管僵硬度对舒张功能的病理生理学作用的认识。

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