Renal Artery Denervation in Chronic Heart Failure Study (REACH)
Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure
研究概览
详细说明
Interventional study
Allocation: Randomised Endpoint Classification: Safety / Efficacy Study Intervention Model: Parallel Assignment Masking: Double blind (Subject / CHF team). The interventional operator, will have no role in care of the patient following randomisation.
Primary Purpose: Treatment
Chronic Systolic Heart Failure
Device: Renal denervation (Symplicity Catheter System) Symplicity Catheter System
-Intervention: Device: Renal denervation (Symplicity Catheter System)
Patients are randomised in the cath lab to receive either renal denervation or sham procedure.
Experimental arm: Renal Denervation Control arm: No renal denervation (sham procedure)
In both arms, aftercare is provided by clinicians who are blinded to the randomised allocation arm. Subjects will have been recruited on stable heart failure therapy, and the intention is to maintain this therapy steady during followup.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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London、英国、W2 1LA
- Imperial College London
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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:
- Chronic heart failure due to systolic dysfunction
- New York Heart Association class II or higher
- Maximal pharmacological therapy including (where clinically indicated and tolerated), b-blocker, ACE inhibitors /A2 blocker, Aldosterone blockade.
- Ejection fraction less than 40%
Exclusion Criteria:
- Estimated GFR<35ml/hr
- Unfavourable renal anatomy (renal artery stenosis)
- Unable to walk on a treadmill for cardiopulmonary exercise test
- Significant valvular disease (moderate or more aortic regurgitation/stenosis or mitral stenosis; severe mitral/tricuspid regurgitation)
- Severe lung disease
- Symptomatic orthostatic dizziness
- Unable to consent
- Pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Renal Denervation
Subjects are treated with renal denervation after randomisation and maintained on heart failure medications
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Symplicity Catheter System
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无干预：Control group
Subject will have a sham procedure and not receive renal denervation.
They will continue with the heart failure medications
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement in symptomatology
大体时间：Baseline to 12 months post-randomization
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Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire
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Baseline to 12 months post-randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement in peak VO2 on cardiopulmonary exercise testing
大体时间：Baseline to 12 months post-randomization
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The peak VO2 will be compared in the interventional against the sham arm
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Baseline to 12 months post-randomization
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Improvement in self-paced exercise distance
大体时间：Baseline to 12 months post-randomization
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Improvement in 6 min walk to in interventional arm compared to sham arm
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Baseline to 12 months post-randomization
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Change in chemoreflex sensitivity
大体时间：Baseline to 12 months post-randomization
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Assess the change in chemoreflex sensitivity in the interventional arm in comparison to the sham arm
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Baseline to 12 months post-randomization
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Change in NYHA functional classification
大体时间：Baseline to 12 months post-randomization
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Assess the change in NYHA in interventional arm in comparison to sham arm
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Baseline to 12 months post-randomization
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Incidence of Major Adverse Events
大体时间：Baseline to 12 months post-randomization
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The incidence of major adverse events will be compared in the interventional against the sham arm
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Baseline to 12 months post-randomization
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合作者和调查者
调查人员
- 研究主任：Darrel P Francis, BA, MD、Imperial College London
- 首席研究员：Justin E Davies, MBBS, PHD、Imperial College London
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
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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