A Randomised Controlled Trial Investigating the Effect of Transcatheter Renal Sympathetic Denervation on Symptoms and Cardiac Function in Patients With Heart Failure With Preserved Ejection Fraction.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Symptoms
研究概览
简要总结
The purpose of this study is to determine whether renal sympathetic denervation (RSD)(a treatment that lowers the activity of the sympathetic nervous system) is useful in the management of patients with heart failure with preserved ejection fraction (HF-PEF).
详细描述
Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in heart failure with preserved left ventricular ejection fraction. The current study aims to evaluate efficacy of renal sympathetic denervation for the modulation of the SNS in patients with HF-PEF.
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
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
- 否
入选标准
- •Evidence of HF-PEF (mixture of dilated left atrium, left ventricular hypertrophy, raised E/E', elevated LVEDP/PCWP, raised BNP)
排除标准
- •Previously documented EF<40%
- •Hypertrophic, restrictive, dilated cardiomyopathy
- •Significant valvular heart disease
- •Unfavourable renal artery anatomy for renal denervation
- •Contraindication to MRI
- •Myocardial infarction, unstable angina or cerebrovascular accident in last 3 months
结局指标
主要结局
Change in Symptoms
时间窗: 12 months
Minnesota Living with Heart Failure Questionnaire
Change in LV remodelling
时间窗: 12 months
LV mass index
Change in Left atrial (LA) size
时间窗: 12 months
LA volume index
Change in Exercise Function
时间窗: 12 months
Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing
Change in Heart Failure Biomarker
时间窗: 12 months
BNP (Natriuretic peptide)
Change in LV (Left Ventricle) filling pressure
时间窗: 12 months
E/E' on echocardiography
次要结局
- Change in Blood pressure(3 and 12 months)
- Change in Renal function(3 and 12 months)
- Change in neurohormones(3 and 12 months)
- Change in Vascular function(3 and 12 months)
- Change in renal blood flow(3 and 12 months)
- Change in Endothelial function(3 and 12 months)
- Change in Autonomic function(3 and 12 months)