Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure
试验速览
- 阶段
- 3 期
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Improvement in symptomatology
研究概览
简要总结
The REACH study, is a prospective, double-blinded, randomised, controlled study of the safety and effectiveness of renal denervation in subjects with chronic systolic heart failure. Bilateral denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radio frequency (RF) energy through the luminal surface of the renal artery.
详细描述
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
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
研究组 & 干预措施
Renal Denervation
Subjects are treated with renal denervation after randomisation and maintained on heart failure medications
干预措施: Renal Denervation (Procedure)
Control group
Subject will have a sham procedure and not receive renal denervation. They will continue with the heart failure medications
结局指标
主要结局
Improvement in symptomatology
时间窗: Baseline to 12 months post-randomization
Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire
次要结局
- Change in NYHA functional classification(Baseline to 12 months post-randomization)
- Improvement in peak VO2 on cardiopulmonary exercise testing(Baseline to 12 months post-randomization)
- Improvement in self-paced exercise distance(Baseline to 12 months post-randomization)
- Change in chemoreflex sensitivity(Baseline to 12 months post-randomization)
- Incidence of Major Adverse Events(Baseline to 12 months post-randomization)