The Effect of Sodium Nitrite Infusion on Renal Variables, Peripheral and Central Blood Pressure in Hypertensive Versus Normotensive Subjects in a Randomised, Placebo Controlled, Cross Over, Case-control Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fractional urinary sodium excretion (FENa)
研究概览
简要总结
The purpose of this study is to investigate how the effect of infused sodium nitrite differs in hypertensives compared to healthy age and sex matched controls. The effects on renal handling of nitrite, nitrate, sodium and water, plasma concentrations of vasoactive hormones, peripheral (brachial) and central blood pressure will be evaluated.
详细描述
Nitric oxide (NO) is an important vasodilating molecule with a very complex biochemistry and metabolism. NO is classically synthesized from L-arginin by endothelial nitric oxide synthase (eNOS) located in the endothelial cell lining. Several chronic cardiovascular diseases such as hypertension, chronic kidney disease and diabetes are accompanied by endothelial dysfunction and hence diminished synthesis of NO. NO is a very reactive molecule and direct investigation of its function are limited and it has mainly been investigated by inhibition of eNOS. Recent research has shown that sodium nitrite is readily converted to NO by enzymes in vivo. The effects of sodium nitrite on renal variables, vasoactive hormones and central blood pressure are previously unexamined. It is now possible to achieve serial estimations of the central aortic systolic pressure (CASP) by a wrist born device.
Hypothesis:
- Sodium nitrite infusion increases the urinary sodium excretion and glomerular filtration rate (GFR)
- Sodium nitrite infusion increases plasma levels of nitrite, nitrate, NO and cyclic guanosine monophosphate (cGMP)
- Sodium nitrite infusion lowers the peripheral and central blood pressure
- Renal clearance of nitrite is constant and not dose dependent
- Sodium nitrite infusion affects vasoactive hormones
- The hemodynamic and renal effects is more pronounced in hypertensives as compared to healthy controls.
Purpose:
The purpose of this study is to investigate the effects of sodium nitrite infusion on
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sodium nitrite
Sodium nitrite, 240 micrograms/kg/hour for 2 hours
干预措施: Sodium nitrite (Drug)
Placebo
Sodium chloride, isotonic 0.9%, 25 ml/hour for 2 hours
干预措施: Sodium chloride (Drug)
结局指标
主要结局
Fractional urinary sodium excretion (FENa)
时间窗: 1 day
次要结局
- Peripheral (brachial) blood pressure(1 day)
- Proximal sodium transport (Estimated by lithium clearance)(1 day)
- Glomerular filtration rate(1 day)
- Urinary excretion of cyclic guanosine monophosphate (cGMP)(1 day)
- Urinary excretion of epithelial sodium channels (ENaC)(1 day)
- Plasma concentration of angiotensin II (ANG2)(1 day)
- Urinary excretion of nitrite and nitrate (NOx)(1 day)
- Free water clearance(1 day)
- Plasma concentration of renin (PRC)(1 day)
- Plasma concentration of aldosterone(1 day)
- Plasma concentration of atrial natriuretic peptide (ANP)(1 day)
- Plasma concentration of brain natriuretic peptide (BNP)(1 day)
- Plasma concentration of cyclic guanosine monophosphate (cGMP)(1 day)
- Plasma concentration of vasopressin (AVP, ADH)(1 day)
- Central aortic systolic blood pressure (CASP)(1 day)
- Plasma concentration of nitrite and nitrate (NOx)(1 day)
- Urinary excretion of aquaporin 2 water channels (AQP2)(1 day)
- Plasma concentration of endothelin(1 day)
研究者
Erling Bjerregaard Pedersen
Chief physician, professor, DMSc
Regional Hospital Holstebro