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临床试验/NCT02597010
NCT02597010已完成不适用

Dietary Nitrate for Resistant Hypertension: A Randomized, Placebo-controlled, Crossover Trial

Royal College of Surgeons, Ireland0 个研究点目标入组 20 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
主要终点
Change in day ambulatory blood pressure

研究概览

简要总结

Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations including newly diagnosed, untreated hypertensives. The additional effect in hypertensives on blood pressure lowering medications is uncertain.

详细描述

Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations including newly diagnosed, untreated hypertensives. The additional effect in hypertensives on blood pressure lowering medications is uncertain.

The investigators hypothesize that chronic nitrate consumption might decrease blood pressure in hypertensives who are suboptimally controlled on at least one blood pressure medication compared to a placebo beetroot juice.

This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with demographics and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 7 consecutive days when assessments will be repeated followed by 7 days of placebo and endpoint assessments or the converse.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically stable,
  • Uncontrolled hypertension

排除标准

  • Pulmonary hypertension
  • Active CVD
  • Taking vasodilators
  • Diabetes mellitus

结局指标

主要结局

Change in day ambulatory blood pressure

时间窗: Day 1, day 15, day 29

次要结局

  • Change in plasma nitrate(Day 1, day 15, day 29)
  • Change in plasma nitrite(Day 1, day 15, day 29)
  • Change in 24h ambulatory blood pressure(Day 1, day 15, day 29)
  • Change in cardiac biomarkers(Day 1, day 15, day 29)
  • Change in night ambulatory blood pressure(Day 1, day 15, day 29)
  • Change in inflammatory biomarkers.(Day 1, day 15, day 29)

研究者

发起方
Royal College of Surgeons, Ireland
申办方类型
Other
责任方
Sponsor

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