Evaluation of the Forecasts Parameters of Real Time Three-dimensional Doppler Echocardiography in Selecting Patients With Chronic Heart Failure for Cardiac Resynchronisation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.
研究概览
简要总结
Patients showing a normal value of SDI (< or + 8%) will randomly be assigned to CRT in "ON" or "OFF"mode at one month after implantation. In any case of emergency, an automated rescue mode is included in the device for the patients in "OFF" mode.
详细描述
Patients with a pathological SDI (> 8%) will as usually be treated by CRT and will serve as control group. The study duration for each patient included in the trial is 6 months. Patients showing a decreased NYHA score by at least one class and an absence of major cardiovascular event during the period will be considered as "good responders". The otherswill be considered as "no responders".
Based on this composite clinical score, the percentage of good responders in each group at 6 months is the primary endpoint of the study.
Main secondary endpoints :
- Evaluation of the left ventricular function
- Exercice capacity
- Serious adverse events'frequency
- Quality of life (SF36)
- Diagnostic and prognostic value of the "Brain Natriuretic Peptide"(NT pro BNP)evolution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single
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
- •* Both gender
- •* Age\>18 years
- •* Patients in functional class NYHA III or IV
- •* Patient with ejection fraction \140msec
- •* Interventricular mechanical delay \>40msec
- •* Delayed activation of the left ventricular postero-lateral wall
- •* Patient under optimal treatment for chronic heart failure for at least one month before inclusion
- •* Written informed consentement
排除标准
- •Patient with atrial fibrillation
- •Absence of echogenicity
- •Patient with an indication for pacemaker implantation
- •Patient suffering from arterial pressure disorders, with systolic pressure greater than 170 or lower than 80 mmHg
- •Major cardiovascular event within 6 weeks before inclusion
- •Patient in the exclusion period of any other clinical trial
- •Patient without social insurance policy
- •Drug or alcohol addiction
- •Any psychological disorder
- •Pregnant women
- •Patient with a transplanted organ
- •HIV positive serology at inclusion
结局指标
主要结局
Three parallel arms, randomized, controlled, single blinded, monocentre, clinical trial.
次要结局
未报告次要终点