Effect of Nitrate Supplementation on Blood Pressure and Systemic Microvascular Function of Resistant Hypertensive Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Assessment of blood pressure evolution
研究概览
简要总结
Arterial hypertension (AH) has been identified as an important public health problem and considered a new epidemic with high mortality and morbidity. High blood pressure (BP) levels increase the chances of coronary artery disease (CAD), heart failure (HF), stroke, chronic renal failure (CRF) and death. Beetroot powder may be an easier way to increase the availability of nitric oxide and consequently vasodilation in these patients. However, studies are needed to evaluate its benefits in patients with AH.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resistant hypertension, with a diagnosis described in the medical record, without changing medications or increasing doses in the last 30 days.
排除标准
- •neoplasms
- •heart failure
- •use of medications with nitrate in their formula
- •patients undergoing renal denervation
研究组 & 干预措施
Placebo
The placebo group will be administered as a colored and flavored isocaloric supplement composed of maltodextrin.
干预措施: Placebo (Dietary Supplement)
Beetroot extract
Beetroot extract powder supplementation with 400mg of nitrate per dose in the amount of 10g per day orally will be used in the group.
干预措施: Beetroot extract (Dietary Supplement)
结局指标
主要结局
Assessment of blood pressure evolution
时间窗: 60 days
Evaluation using Ambulatory Blood Pressure Monitoring: systolic, diastolic and mean arterial pressures
次要结局
未报告次要终点
研究者
Eduardo Tibirica, MD, PhD
Senior Researcher
National Institute of Cardiology, Laranjeiras, Brazil