Phase 3 Study of Renal Denervation That Improves Symptoms of Heart Failure and Enhances Life Quality in Advanced Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
研究概览
简要总结
Sympathetic system has important role occurrence of symptoms in heart failure. Renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. This interventional therapy improves symptoms and life quality.
详细描述
Primary Outcome Measures:
• Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
Secondary Outcome Measures:
• Ventricular function,NYHA functional Class, 6 min walking test, biochemical test and Renal function as measured by Glomerular Filtration Rate (GFR)
Eligibility Patients population: Volunteers, NYHA Class III-IV heart failure patients. Ages Eligible for Study: 18 Years to 85 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
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
- •Heart Failure patients NYHA Class III or IV
- •Left Ventricular Ejection Function < 35%
- •GFR > 45 mL/min/1.73m2
- •Optimal stable medical therapy
排除标准
- •Do not eligible renal artery anatomy for treatment as determined by Angiography, and
- •History of prior renal artery intervention
- •Single functioning kidney.
- •Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
- •Systolic BP < 110mmHG Hospitalisation because of heart failure in last 3 weeks.
结局指标
主要结局
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
时间窗: 6 months
次要结局
- • Ventricular function as measured by Echocardiography • NYHA functional Class, 6 min walking test, biochemical test. • Renal function as measured by Glomerular Filtration Rate (GFR)(6 months)
研究者
Hasan ARI
Medical Doctor, Cardiology Chief Intern
Bursa Postgraduate Hospital