Effects of Chronic Remote Ischaemic Conditioning on Coronary and Peripheral Vascular Function in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Myocardial perfusion reserve
研究概览
简要总结
This study will test the impact of remote ischaemic conditioning combined with exercise on myocardial perfusion in patients with or at risk of heart failure
详细描述
Heart failure (HF) is a disease which affects the heart's ability to pump or fill with blood. It can affect a person's quality of life and their ability to exercise. Recent work has shown that a reduction in the blood supply to the heart may contribute to the problem. It is therefore possible that improving the blood supply to the heart may help patients with HF. One possible way that this might be achieved is with a method called remote ischaemic conditioning (RIC). This involves placing a cuff on a person's arm (identical to a blood pressure cuff) and inflating it for a few minutes to reduce the blood flow in a person's arm. This is thought to release chemicals into the bloodstream which can have positive effects on the heart. This has been studied in patients with other forms of heart disease, but is yet to be tested properly in patients with heart failure. It is hypothesized that combining the RIC procedure with a low level of arm exercise may result in further improvements in the person's blood vessels and heart. This will be tested in a single-centre prospective study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Blinded analysis of data
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Ability to provide written consent
- •clinical diagnosis of HFpEF (LVEF ≥50%; symptoms and signs of heart failure [HF] caused by a structural and/or functional abnormality, and at least one: elevated natriuretic peptides; ambulatory; BNP ≥35 pg/mL or NT-proBNP ≥125 pg/mL or hospitalised; BNP ≥100 pg/mL or NT-proBNP ≥300 pg/mL, and objective evidence of cardiogenic pulmonary or systemic congestion) OR stable type 2 diabetes (determined by formal diagnosis in hospital or GP case records with diagnostic oral glucose tolerance test or glycated haemoglobin level ≥6.5%) and with ACC/AHA stage B HF (structural disorder of the heart but no current or previous symptoms of HF) OR confirmed diagnosis of dilated cardiomyopathy
排除标准
- •Absolute contraindications to MRI or contrast (e.g. severe claustrophobia, pregnancy, ferromagnetic implants, inability to lie flat, severe renal impairment eGFR<30ml/min/m2)
- •Moderate to severe valvular heart disease
- •Confirmed coronary artery disease (>50% narrowing in any major epicardial coronary artery on invasive or computed tomography coronary angiography, previous myocardial infarction, previous percutaneous intervention or coronary bypass surgery)
- •Known arterial stenosis of the upper extremity
结局指标
主要结局
Myocardial perfusion reserve
时间窗: 4 weeks
myocardial perfusion reserve under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR)
Contraction strength in the cuff deflation phase of RIC
时间窗: 1 day
contraction force achieved during cuff deflation phase, measured in Newtons
Hyperaemic myocardial blood flow
时间窗: 4 weeks
myocardial blood flow under adenosine stress as assessed by quantitative cardiovascular magnetic resonance (CMR)
次要结局
- Brachial artery flow mediated dilation(4 weeks)
- Skeletal muscle strength(4 weeks)
- Skeletal muscle endurance(4 weeks)
- Cardiopulmonary exercise test(4 weeks)
- Brachial artery maximal dilatory capacity(4 weeks)