Investigating the Interaction of Apelin and Systemic Angiotensin II Peripheral Resistance Vessels and Systemic Haemodynamics in Vivo in Man
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in cardiac output
研究概览
简要总结
The apelin-APJ system is a relatively new discovery. It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease.
Two of the main actions of apelin are to increase the pumping ability of the heart and cause blood vessels to relax. The investigators wish to assess if these actions are altered in the setting of normal renin-angiotensin activation and increased renin-angiotensin activity.
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 (Investigator)
入排标准
- 年龄范围
- 18 Months 至 85 Years（Child, 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
- •Lack of informed consent
- •Age < 18 years,
- •Current involvement in other research studies,
- •Systolic blood pressure >190 mmHg or <100 mmHg
- •Malignant arrhythmias
- •Renal or hepatic failure
- •Haemodynamically significant aortic stenosis
- •Severe or significant co morbidity
- •Women of childbearing potential.
- •Any regular medication
- •Previous history of any cardiovascular disease
研究组 & 干预措施
Sodium depletion
Subjects will be randomised to normal diet or sodium depleted diet. The sodium depletion protocol comprises of a single oral dose of 40 mg of furosemide followed by an out-patient diet containing >2000 kcal of energy, >60 g of protein, <12 mmol of sodium and <70 mmol of potassium per day for 3 days prior to study. This diet is know to increase the activity of the renin-angiotensin system.
干预措施: Apelin (Drug)
Sodium depletion
Subjects will be randomised to normal diet or sodium depleted diet. The sodium depletion protocol comprises of a single oral dose of 40 mg of furosemide followed by an out-patient diet containing >2000 kcal of energy, >60 g of protein, <12 mmol of sodium and <70 mmol of potassium per day for 3 days prior to study. This diet is know to increase the activity of the renin-angiotensin system.
干预措施: Acetylcholine (Drug)
Sodium depletion
Subjects will be randomised to normal diet or sodium depleted diet. The sodium depletion protocol comprises of a single oral dose of 40 mg of furosemide followed by an out-patient diet containing >2000 kcal of energy, >60 g of protein, <12 mmol of sodium and <70 mmol of potassium per day for 3 days prior to study. This diet is know to increase the activity of the renin-angiotensin system.
干预措施: Sodium nitroprusside (Drug)
Sodium depletion
Subjects will be randomised to normal diet or sodium depleted diet. The sodium depletion protocol comprises of a single oral dose of 40 mg of furosemide followed by an out-patient diet containing >2000 kcal of energy, >60 g of protein, <12 mmol of sodium and <70 mmol of potassium per day for 3 days prior to study. This diet is know to increase the activity of the renin-angiotensin system.
干预措施: Systemic apelin infusion (Drug)
Normal diet
Subjects will be randomised to a normal diet, with no restriction on sodium intake during the three days prior to the study.
干预措施: Apelin (Drug)
Normal diet
Subjects will be randomised to a normal diet, with no restriction on sodium intake during the three days prior to the study.
干预措施: Acetylcholine (Drug)
Normal diet
Subjects will be randomised to a normal diet, with no restriction on sodium intake during the three days prior to the study.
干预措施: Sodium nitroprusside (Drug)
Normal diet
Subjects will be randomised to a normal diet, with no restriction on sodium intake during the three days prior to the study.
干预措施: Systemic apelin infusion (Drug)
结局指标
主要结局
Change in cardiac output
时间窗: 12 months
Change in apelin mediated vasodilatation
时间窗: 12 months
次要结局
- Change in relevant neurohumoral hormones(12 months)
- Change in systemic haemodynamics(12 months)