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甜菜根汁降低常染色体显性遗传多囊肾病(BEET-PKD)高血压成人血压的疗效:一项双盲、随机、安慰剂对照试验的研究方案。

Efficacy of beetroot juice on reducing blood pressure in hypertensive adults with autosomal dominant polycystic kidney disease (BEET-PKD): study protocol for a double-blind, randomised, placebo-controlled trial.

机构信息

Michael Stern Laboratory for Polycystic Kidney Disease, Westmead Institute for Medical Research, The University of Sydney, Sydney, NSW, 2145, Australia.

Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District, Sydney, NSW, 2145, Australia.

出版信息

Trials. 2023 Jul 29;24(1):482. doi: 10.1186/s13063-023-07519-2.

Abstract

BACKGROUND

In autosomal dominant polycystic kidney disease (ADPKD) impaired nitric oxide (NO) synthesis, in part, contributes to early-onset hypertension. Beetroot juice (BRJ) reduces blood pressure (BP) by increasing NO-mediated vasodilation. The aim of this double-blind, randomised, placebo-controlled study is to test the hypothesis that BRJ reduces systolic and diastolic clinic BP in hypertensive adults with ADPKD.

METHODS

Participants with ADPKD and treated hypertension (n = 60) will be randomly allocated (1:1) to receive a daily dose of either nitrate-replete (400 mg nitrate/day) or nitrate-deplete BRJ for 4 weeks. The co-primary outcomes are change in mean systolic and diastolic clinic BP before and after 4 weeks of treatment with daily BRJ. Secondary outcomes are changes in daily home BP, urinary albumin to creatinine ratio, serum and salivary nitrate/nitrite levels and serum asymmetric dimethylarginine levels before and after 4 weeks of BRJ.

DISCUSSION

The effect of BRJ in ADPKD has not been previously tested. BRJ is an accessible, natural dietary supplement that, if effective, will provide a novel adjunctive approach for treating hypertension in ADPKD.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05401409. Retrospectively registered on 27th May 2022.

摘要

背景

在常染色体显性多囊肾病(ADPKD)中,一氧化氮(NO)合成受损部分导致早期高血压。甜菜根汁(BRJ)通过增加 NO 介导的血管扩张来降低血压(BP)。本双盲、随机、安慰剂对照研究的目的是检验 BRJ 是否可以降低 ADPKD 高血压患者的收缩压和舒张压的假设。

方法

将 60 名患有 ADPKD 和治疗性高血压的参与者(n=60)随机分配(1:1)接受每日剂量的富含硝酸盐(400mg 硝酸盐/天)或硝酸盐缺乏 BRJ 治疗 4 周。主要结局是在 BRJ 治疗 4 周前后,平均收缩压和舒张压的变化。次要结局是 4 周 BRJ 治疗前后的每日家庭血压、尿白蛋白与肌酐比值、血清和唾液硝酸盐/亚硝酸盐水平以及血清不对称二甲基精氨酸水平的变化。

讨论

BRJ 在 ADPKD 中的作用尚未经过测试。BRJ 是一种易于获得的天然膳食补充剂,如果有效,将为治疗 ADPKD 中的高血压提供一种新的辅助方法。

试验注册

ClinicalTrials.gov NCT05401409。2022 年 5 月 27 日回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4b3/10386227/8d63fc0c37b1/13063_2023_7519_Fig1_HTML.jpg

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