Investigating the Inotropic Potential of Apelin in Healthy Volunteers and Patients With Chronic Stable Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- cardiac output
研究概览
简要总结
The apelin-APJ system is a recently discover hormone system that has several important actions in the cardiovascular system. Apelin causes the heart pump with more force and also causes blood vessels to relax. Studies to date show that people with reduced pumping function of the heart have lower levels of apelin in the bloodstream compared to people with normal heart function. We have previously given apelin to healthy volunteers and people with reduced pumping function and this increases the heart's contraction. However, this has only been assessed over a short time period, around fifteen minutes, and we now want to know if this effect is seen over a longer period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers:
- •Heart failure patients;
- •New York Heart Failure class II-IV
- •Ejection fractional <35% or fractional shortening <20% within previous 6months.
排除标准
- •All subjects,
- •Females of child bearing age not on adequate contraception
- •Lack of informed consent
- •Age <18yrs
- •Current involvement in any other research study
- •Systolic BP >190 or <100
- •Malignant arrhythmias
- •Renal or hepatic failure
- •Haemodynamically significant aortic stenosis
- •Severe or significant co-morbidity
- •Pacemakers
- •Healthy volunteers
- •Any regular medication
- •Previous history of any cardiovascular disease
研究组 & 干预措施
Apelin infusion
6 hour infusion of apelin peptide into circulation
干预措施: Apelin (Drug)
Placebo
Infusion of saline into systemic circulation
干预措施: Placebo (Drug)
结局指标
主要结局
cardiac output
时间窗: 6 hours
We will assess, using thoracic bioimpedance cardiography, the change in cardiac output in response to apelin infusion
次要结局
- Urine volume(6 hours)
- Pulmonary artery pressure(1 hour)