Evaluation à Six Mois du système de dénervation rénale Chez Les Patients Atteints d'Insuffisance Cardiaque
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Significant improvement of the 6 minutes walk test
研究概览
简要总结
Management of chronic heart failure (CHF) is a major public health problem. It is associated with high mortality, frequent hospitalization and represents a large cost to the health care system. Both pharmacological and non-pharmacological intervention haven't shown to be effective in reducing morbidity and mortality of these patients when able to modulate the activity of neuro-hormonal systems among them the sympathetic nervous system. Recent data have emphasized the potential role of sympathetic renal denervation in patient with hypertension. CHF per se but even more CHF associated with comorbity lead to significant increase level of sympathetic tone. This is largely induced by autonomic dysfunction such as chemo or baroflex abnormalities. These patients usually suffer from conditions which do not allow upgrading and adapting drugs to their sympathetic condition. Hence CHF patient with chronic kidney disease, anemia or both have markedly high sympathetic activity and cannot be exposed to higher level of RAS Blockers or beta blocker due to their renal dysfunction, they thus remain with an elevated sympathetic activity worsening symptoms and prognosis. Chronic heart failure affects around 100 million people worldwild imposing a significant burden on health care system throughout the world. Even though symptoms are improved by heart failure therapy, they remain significantly disabling for many patients. Chronic over activation of the sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs. A new therapy directly targeting nerve traffic-renal artery denervation- has been shown to be effective in drug resistant hypertension, with an average drop in blood pressure of 33/12 mm hg.
The cardiologists team of the private hospital Arnault Tzanck is willing therefore to conduct a study in 12 patients with chronic systolic heart failure undergoing bilateral renal denervation with an intensive protocol of observation and assessment compring a 3 day hospital stay post procedure 3 and 6 months of regular outpatient follow-up.
详细描述
Renal denervation is a new interventional cardiology technique that involves using a catheter and a femoral artery, inserting an RF probe that will destroy the nerve fibers in contact with the wall of the renal artery with a very small electric current.
The method utilizes the energy emitted by a miniaturized device positioned at the end of a catheter. This catheter is positioned in the arteries going to the kidneys.
Sympathetic overactivation, is reduced by renal denervation in drug-resistant hypertension. Several studies conducted in patients without heart failure showed that renal denervation reduces left ventricular hypertrophy beyond its only effect on blood pressure.
Chronic over activation of the sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs.
The purpose of this Clinical investigation is to evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with chronique heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable chronic heart failure
- •NYHA III-IV
- •LV EF <35 assessed by ultrasound
- •EGFR> 45ml / min / 1.73m2
- •Optimal therapeutic treatment
- •IMC : 17-24
排除标准
- •significant renovascular abnormalities such as renal artery stenosis> 30%.
- •renal angioplasty history, renal denervation, stent placement
- •hemodynamically significant valvular heart disease
- •an active systemic infection.
- •renal artery of <4 mm.
- •coagulation abnormalities.
- •kidney transplant or is waiting for a kidney transplant.
- •life expectancy of less than 12 months (seatle score).
- •femoral-iliac atherosclerotic
结局指标
主要结局
Significant improvement of the 6 minutes walk test
时间窗: 6 months
The primary efficacy end point is the assessment at 6 months post renal denervation of the improvement in symptomatology as BNP level or VO2 max or pharmacological therapy from baseline
次要结局
- Incidence of adverse events(5 months)
- Quality of life evaluated by EQ-5D. 1(before intervention and after 6 months)
