Cardiopulmonary Exercise Test Predicts Long-term Survival and Positive Response to Cardiac Resynchronization Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 主要终点
- Death
研究概览
简要总结
The study tested the usefulness of cardiopulmonary exercise test (CPET) in selection of potential responders to CRT.
详细描述
Cardiac resynchronization therapy (CRT) is an acknowledged therapy of selected patients with heart failure (HF). One of the unresolved problems is high percentage of non-responders to CRT, reaching 40%. No single parameter, helpful in identifying non-responders prior to CRT implantation, was found.
The study included patients with HF of ischemic or non-ischemic etiology, in NYHA class II-IV, EF≤35% and QRS≥120ms. All the patients had CRT implanted. Clinical evaluation, CPET and NT-proBNP levels measurement were performed before CRT implantation and after 3-6 months. Improvement in HF symptoms of one or more NYHA class correlated with two-years survival. It was used as the criterion of positive response to CRT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •HF in class III or IV according to New York Heart Association (NYHA) in the course of ischemic (ICM) or non-ischemic cardiomyopathy (NICM), QRS complex duration ≥ 120ms, EF ≤35% and dilatation of the left ventricle diastolic diameter >55mm (LVdD), according to the ESC guidelines in 2007
- •HF in NYHA class II, LBBB with QRS complex duration ≥ 150 ms according to the guidelines update in 2010
- •optimal pharmacotherapy of HF in the period of three months prior to the study entry.
- •the expected survival of the patient > 1 year.
排除标准
- •severe chronic obstructive pulmonary disease (FEV1 <30%)
- •inability to perform a stress test on a treadmill
结局指标
主要结局
Death
时间窗: Follow up within 5 years from CRT
All cause death, data from hospital entries and phone follow-up .
Heart transplantation
时间窗: Follow up within 5 years from CRT
Heart transplantation as the definitive therapy of end-stage heart failure.
次要结局
- Positive response to CRT(Follow up within 1 year from CRT)