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