Cardiovascular Effects of Apelin In Healthy Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in cardiac output between different methods of apelin administration.
研究概览
简要总结
Apelin is an endogenous peptide with physiological actions in the cardiovascular system. Apelin can modulate vasomotor tone and is a potent endogenous inotrope. In a series of clinical studies, we have shown that apelin causes peripheral and coronary vasodilatation and increased cardiac contractility. We wish to study and compare the cardiovascular effects of subcutaneous versus intravenous apelin. We specifically wish to determine how different methods of apelin administration affect cardiac output and peripheral vascular resistance in healthy volunteers
详细描述
Study Protocols Groups of 5 subjects will be assigned to receive one of three protocols.
Protocol 1:
Five healthy volunteers will be asked to attend the clinical research facility on a total of 4 occasions as per the protocol below.
Visits 1 and 2 will occur over two consecutive days. Participants will attend at 07.30 and be given a light breakfast. An intravenous sampling cannula will be inserted into the antecubital vein of one arm. Blood samples (5 mL) will be taken immediately prior to subcutaneous injection (t=0; 08.00) of 1 mg (Pyr1)apelin-13 and at 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 600 min after injection. Subjects will then be discharged from the facility and reattend the following day at 08.00 for a single venous sample. Approximately 85 mL of blood will be sampled in total over this time.
Visits 3 and 4 will also occur over two consecutive days, at least one week after visit 2. Subjects will attend at 07.30 and be given a light breakfast. An intravenous sampling cannula will be inserted into the antecubital vein of one arm. Blood samples (5 mL) will be taken immediately prior to an intravenous bolus infusion (t=0; 08.00) of 1 mg (Pyr1)apelin-13 over 15 min and at 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 600 min after injection. Subjects will then be discharged from the facility and reattend the following day at 08.00 for a single venous sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females >18 years old
- •Willing and able to complete an informed consent form
排除标准
- •Unable to give informed consent
- •Pregnant or lactating at screening
- •Use of any investigation product or device within 30 days prior to study.
研究组 & 干预措施
Protocol 1. Apelin 1mg doses
5 Healthy volunteers
干预措施: Apelin 1mg subcutaneous (Drug)
Protocol 1. Apelin 1mg doses
5 Healthy volunteers
干预措施: Apelin 1mg intravenous (Drug)
Protocol 2. Apelin 5mg doses
5 Healthy volunteers
干预措施: Apelin 5mg subcutaneous (Drug)
Protocol 2. Apelin 5mg doses
5 Healthy volunteers
干预措施: Apelin 5mg intravenous (Drug)
Protocol 3. Apelin 10mg single dose
5 Healthy volunteers
干预措施: Apelin 10 mg subcutaneous (Drug)
结局指标
主要结局
Change in cardiac output between different methods of apelin administration.
时间窗: 10 hours
Difference in cardiac output between different treatment arms. This will be assessed by recording cardiac index in L/min/m2 and Stroke volume index mL/min/m2
Change in blood pressure between different methods of apelin administration.
时间窗: 10 hours
Difference in blood pressure between different treatment arms assessed by measuring mean blood pressure in mmHg. Mean arterial pressure (MAP) will be calculated as diastolic blood pressure plus a third of the pulse pressure
次要结局
- Change in apelin concentrations between the different methods of administration(24 hours)