Sodium Nitrate to Improve Blood Flow
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- change in muscle tissue oxygenation
研究概览
简要总结
Investigators recently showed that tadalafil restores functional sympatholysis in patients with Becker muscular dystrophy (BMD). If tadalafil restores functional sympatholysis in BMD via the NO-cyclic guanosine monophosphate pathway, then functional sympatholysis should also be restored by sodium nitrite- which is an indirect nitric oxide donor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Becker muscular dystrophy
- •age 15-55 years of age
- •ambulatory
排除标准
- •hypertension, diabetes, or heart failure by standard clinical criteria
- •elevated brain natriuretic peptide level (>100 pg/ml)
- •Left ventricular ejection fraction < 50%
- •cardiac rhythm disorder, specifically: rhythm other than sinus, supraventricular tachycardia, atrial fibrillation, ventricular tachycardia, heart block
- •continuous ventilatory support
- •liver disease
- •renal impairment
- •history of asthma or bronchospasm
- •use of any medications other than common supplements
- •unable to perform handgrip exercise
研究组 & 干预措施
Sodium nitrate
Sodium nitrate will be administered orally and functional sympatholysis assessed before and after treatment
干预措施: Sodium nitrate (Dietary Supplement)
结局指标
主要结局
change in muscle tissue oxygenation
时间窗: change from baseline to post treatment (3-4 hours)
The pre-specified primary outcome is the pre vs. post treatment change in functional sympatholysis measured by muscle oxygenation.
次要结局
未报告次要终点
研究者
Ron Victor
Professor of Medicine
Cedars-Sinai Medical Center