Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures
Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures.
The investigators are interested in studying how Pulmonary Hypertension occurs. A substance called 'apelin', that naturally occurs in the body has been shown to have an important role in heart disease. Previous studies have shown that it can make blood vessels get wider, and help blood flow around the body and thus improve the way the heart and lungs work.
The investigators are looking to recruit both healthy and COPD pulmonary hypertension patients to study 3 types of apelin. The purpose of this study is to help the investigators understand how Pulmonary Hypertension occurs which may will help with the development of future treatments.
研究概览
详细说明
The purpose of this study:
To investigate the physiological role of apelin in the cardiovascular system in patients with COPD with raised pulmonary artery pressures.
Study Aim and hypotheses:
The primary objective is to test the above hypotheses using forearm blood flow and systemic infusions of apelin peptides.
Hypotheses:
- Apelin agonists are vasodilators in human resistance vessels and this effect will be altered in patients with pulmonary hypertension.
- Apelin peptides improve right ventricular and pulmonary haemodynamics in patients with elevated pulmonary artery pressures.
Study 1a - A validation dose study of 3 apelin agonists performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 1b- A validation dose study of apelin receptor antagonist, in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 2a - To define the haemodynamic response to apelin agonists in healthy volunteers and evaluate the response.
Study 2b - To investigate the haemodynamic response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Cambridge、英国、CB2 0QQ
- Vascular Research Unit, Clinical Pharmacology Unit, ACCI, Level 3, Addenbrooke's Hospital, Hills Road
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Healthy volunteers
- Aged 18 to 70 years
- Non-smoker (<1 cigarette per week)
- If female, postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test COPD patients with estimated Pulmonary Artery Pressure (PAP) on echo >25mmHg
- Clinical diagnosis of COPD as per standard criteria
- Between 18 and 70 years
- If female, postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test
Exclusion Criteria:
pre-existing:
- Systemic Hypertension (sustained BP >160/100mmHg)
- Ischaemic Heart Disease
- Primary valvular heart disease
- Significant left ventricular failure
- Active malignancy
- Renal disease (Creatinine >180 µmol/L)
- Neurological disease
- Diabetes mellitus
- BMI >35, BMI <17
- Pregnancy
- Use of vasoactive medication or NSAIDS/aspirin within 48 hours of study.
- Current involvement in other research studies, other than observational/non-interventional
- Known HIV
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Systemic Apelin infusion
Study 2a - Haemodynamic studies to investigate the response to systemic infusions of 3 apelin agonists in healthy volunteers Study 2b - Haemodynamic studies to investigate the response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures |
Dose response study
其他名称：
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实验性的：Apelin infusion - forearm
Study 1a - A validation dose study of 3 apelin agonists using forearm plethysmography to evaluate changes in forearm blood flow: performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures. Study 1b- A validation dose study of apelin receptor antagonist using forearm plethysmography to evaluate changes in forearm blood flow, in healthy volunteers and COPD patients with elevated pulmonary artery pressures. |
Dose response study
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Percentage change in forearm blood flow in the infused arm. Forearm blood flow ratio in each arm, blood pressure and heart rate will also be reported.
大体时间：12 months
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12 months
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Cardiac output and stroke volume, pulmonary vascular resistance, mean arterial pressure and heart rate.
大体时间：12 months
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12 months
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Exploratory endpoints in Study 2 are systolic and diastolic blood pressure.
大体时间：12 months
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12 months
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合作者和调查者
调查人员
- 首席研究员：Dr. Joseph Cheriyan, MD、Cambridge University Hospitals NHS Foundation Trust
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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