BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in VO2 submax and or VO2 max
研究概览
简要总结
The study is a single center randomised, double-blind, placebo-controlled crossover study to assess the effects of beetroot juice in patients with pulmonary arterial hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PAH (pulmonary arterial hypertension)
- •WHO functional class II-III
排除标准
- •WHO functional class I or IV
- •pregnancy
- •known intolerance or allergy to beetroot
- •treatment with Allopurinol
- •treatment with Iloprost (inhaled)
- •systolic bloodpressure < 95 mmHg
- •diabetes mellitus type 2
研究组 & 干预措施
Nitrate rich beetroot juice
Eligible subjects will be randomised, in a double-blind crossover design, to receive treatment with either nitrate rich beetroot juice (70 ml containing approximately 8 mmol nitrate - active comparator) or nitrate depleted beetroot juice (70 ml - placebo) twice daily for 7 days (treatment period 1) followed by a 7 day washout period followed by treatment twice daily with the active comparator or placebo depending on initial treatment for another 7 days (treatment period 2) .
干预措施: Beetroot juice (Dietary Supplement)
Nitrate depleted beetroot juice
Eligible subjects will be randomised, in a double-blind crossover design, to receive treatment with either nitrate rich beetroot juice (70 ml containing approximately 8 mmol nitrate - active comparator) or nitrate depleted beetroot juice (70 ml - placebo)twice daily for 7 days (treatment period 1) followed by a 7 day washout period followed by treatment twice daily with the active comparator or placebo depending on initial treatment for another 7 days (treatment period 2) .
干预措施: Beetroot juice (Dietary Supplement)
结局指标
主要结局
Change in VO2 submax and or VO2 max
时间窗: 7 days
次要结局
- Change in WHO functional class(7 days)
- Change in 6MWT(7 days)
- Change in NT-pro-BNP(7 days)
- Change in systemic bloodpressure(7 days)
- Change in echocardiographic parameters(7 days)
- Change in exhaled NO(7 days)
- Change in metabolic pathways involved in nitric oxide production and regulation(7 days)