Urocortins 2 & 3-Effects on Forearm Arterial Blood Flow in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Forearm blood flow
研究概览
简要总结
Despite modern advances in treatment, heart failure continues to carry a poor prognosis with high morbidity and mortality rates. Hence, there remains a major interest in the development of novel therapeutic agents for this debilitating condition. Urocortins have recently shot into limelight with their potential role in the pathophysiology and treatment of heart failure.
Recent studies by the investigators group (REC no: 09/S1103/41) have confirmed that Urocortin 2 and 3 are potent arterial vasodilators, the effects of which are reproducible and well tolerated in healthy male volunteers. Previous studies using heart failure models in animals1-7, as well studies in heart failure patients (Urocortin 2), suggest that there is great scope for Urocortins as novel biomarkers and as potential therapeutic agents in heart failure. With this in mind, the investigators wish to study the local vasomotor effects of these peptides in greater detail in patients with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with heart failure:
- •Patients with stable heart failure (NYHA class II-IV) on maximum tolerated doses of an ACE inhibitor and beta-blocker for at least 3 months.
- •Baseline echocardiographic parameters (echo performed within last 12 months) at recruitment: ejection fraction (EF) <35%, left ventricular end dimension >5.5cm and fractional shortening <20%
- •Age 18-80 years (inclusive) at recruitment
- •Healthy volunteers:
- •Age and sex-matched healthy volunteers
排除标准
- •Lack of informed consent
- •Age <18 years and > 80 years
- •Current involvement in a clinical trial
- •Systolic blood pressure >190 mmHg or <90 mmHg, untreated malignant arrhythmias
- •Haemodynamically significant valvular heart disease
- •Severe or significant co-morbidity including bleeding diathesis, renal or hepatic failure
- •History of anaemia
- •Recent infective/inflammatory condition
- •Recent blood donation (prior 3 months)
- •Women of child bearing potential
研究组 & 干预措施
Patients with heart failure
Assessing the response to infusion of intra-arterial Urocortin 2, 3 and Substance P in patients with heart failure
干预措施: Urocortin 2, Urocortin 3 and Substance P (Drug)
Healthy controls
Assessing response to intra-arterial infusions of Urocortin 2, 3 and Substance P in age and sex-matched healthy volunteers as controls.
干预措施: Urocortin 2, Urocortin 3 and Substance P (Drug)
结局指标
主要结局
Forearm blood flow
时间窗: 3 hours
Difference between forearm blood flow in response to doses of Ucn2, Ucn3 and Substance P between heart failure patients and healthy controls.
次要结局
- Absolute forearm blood flow(3 hours)