Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cardiac output and stroke volume, pulmonary vascular resistance, mean arterial pressure and heart rate.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cardiac output and stroke volume, pulmonary vascular resistance, mean arterial pressure and heart rate.
时间窗: 12 months
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.
时间窗: 12 months
次要结局
未报告次要终点
研究者
Joseph Cheriyan, MD
Consultant Physician & Clinical Pharmacologist
Cambridge University Hospitals NHS Foundation Trust