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临床试验/NCT02471417
NCT02471417已完成不适用

Dietary Nitrate Supplementation in Dilated Cardiomyopathy: An Acute, Double-blind, Randomized, Placebo-controlled, Crossover Trial.

Royal College of Surgeons, Ireland0 个研究点目标入组 12 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
12
主要终点
Change between incremental shuttle walk test distance pre and post juice

研究概览

简要总结

Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with both peripheral vascular disease or COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot juice.

详细描述

Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with both peripheral vascular disease or COPD. Many patients with dilated cardiomyopathy have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in dilated cardiomyopathy subjects compared to a placebo beetroot juice. This study is a randomized, double-blind placebo-controlled, crossover trial. Resting blood pressure, phlebotomy and ISWT will be performed. Following completion, each subject is randomized to consume beetroot juice or placebo. 3 hours later, the same assessments are repeated by the same people. After a 7d washout, the entire protocol is repeated with the crossover beverage.

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

接受健康志愿者

入选标准

  • Clinically stable,
  • Confirmed non-ischemic, dilated cardiomyopathy

排除标准

  • Active musculo-skeletal conditions
  • Ischemic heart disease
  • Pulmonary hypertension
  • Taking vasodilators
  • Diabetes mellitus

结局指标

主要结局

Change between incremental shuttle walk test distance pre and post juice

时间窗: Day 1 and day 8

次要结局

  • Clinic blood pressure(Day 1 and day 8)
  • Dyspnoea using self report, validated Borg scale(Day 1 and day 8)
  • Plasma nitrate(Day 1 and day 8)
  • Oxygen saturation using pulse oximetry(Day 1 and day 8)
  • Plasma nitrite(Day 1 and day 8)

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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