Effects of Cardiac Resynchronization Therapy on Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Exercise endurance time
研究概览
简要总结
A new therapy for patients with advanced heart failure (HF) involves the implantation of a specialized pacemaker device (Cardiac Resynchronization Therapy, CRT) that attempts to restore the synchronized contraction of the ventricular chambers of the heart. In some people, CRT improves exertional breathlessness and allows them to exercise for longer periods. However, to date, the mechanisms by which CRT improves symptoms and exercise tolerance is unknown. This study will use in-depth cardiopulmonary exercise testing and pulmonary function testing to explore these mechanisms in greater detail.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically stable
- •being considered for implantation of biventricular pacemaker for CRT
- •LVEF <35%
- •QRS duration >120 msec
- •NYHA III-IV functional class
- •optimized pharmacologic management of CHF
- •no recent (<1 month) episodes of decompensated CHF
排除标准
- •inability to perform cycle ergometry or comply with testing
- •uncontrolled ischemic heart disease
- •coronary revascularization within 3 months of study entry
- •concurrent primary lung disease
- •current use of ambulatory oxygen
- •rhythm other than sinus
- •dependency on pacemaker therapy as a consequence of bradyarrhythmias
- •severe valvulopathy
研究组 & 干预措施
CRT-ON/CRT-OFF
Group initially randomized to CRT-ON, then cross-over to CRT-OFF
干预措施: Active Cardiac Resynchronization Therapy (CRT) (Device)
CRT-OFF/CRT-ON
Group initially randomized to CRT-OFF, then cross-over to CRT-ON
干预措施: Active Cardiac Resynchronization Therapy (CRT) (Device)
结局指标
主要结局
Exercise endurance time
时间窗: 6 weeks
次要结局
未报告次要终点