Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of hospitalizations due to heart failure worsening.
研究概览
简要总结
Chronic heart failure is becoming more and more common disease and activation of sympathetic nervous system plays a crucial role in its development. There is some data allowing to suspect that one of the new treatment methods- renal denervation, also in patients with chronic heart failure may lead to decrease of systemic activity sympathetic nervous system and, as a consequence, to decrease of disease progression. The research hypothesis is whether renal denervation in case of symptomatic heart failure, even the optimal treatment therapy is used (including resynchronization therapy), is contributing to the improvement in parameters of neurohormonal activation, hemodynamics and clinical patient status. The aim of the study is to obtain a new knowledge concerning renal denervation in chronic heart failure, So far only very limited data- mostly case reports- are available in this study area.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 year
- •heart failure patients NYHA Class II - IV
- •implanted resynchronization pacemaker according to current european guidelines at least 6 months earlier
- •symptoms of heart failure even on optimal pharmacological therapy including resynchronization therapy (lack of improvement within dyspnoea and exercise tolerance after the procedure)
- •left ventricular ejection function ≤ 35%
- •glomerular filtration rate (eGFR according to MDRD formula ≥ 30 mL/min/1.73m2)
- •patient informed consent for participation in the study
排除标准
- •renal artery anatomy not eligible for denervation (at least 4 mm diameter, 20 mm in length)
- •history of prior renal artery intervention
- •single functioning kidney
- •clinic systolic BP < 110mmHg
- •acute coronary syndrome or cerebrovascular event within last 3 months
- •serious medical conditions which may adversely affect safety- clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders (thrombocytopenia, hemophilia, or significant anemia)
结局指标
主要结局
Number of hospitalizations due to heart failure worsening.
时间窗: one year
Change in NYHA class.
时间窗: one year
Change in 6 minute walk test distance.
时间窗: one year
次要结局
未报告次要终点
研究者
Aleksander Kusiak
MD, PhD
Jagiellonian University