Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life: A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 9
- 主要终点
- Clinical parameters most likely to be impacted by hemodynamic-echo ramp tests
研究概览
简要总结
The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp Tests to determine which method of testing provides better information for adjusting pump speed and medical treatment for Left Ventricular Assist Device (LVAD) patients. Better adjustments may provide better quality of life, exercise tolerance and reduced unwanted cardiac events over a 6-month period.
详细描述
All Left Ventricular Assist Device (LVAD)patients undergo testing to determine the best pumping speed for their Left Ventricular Assist Device (LVAD) and to gather measurements that help guide medical treatment. The testing uses echocardiography ("echo", ultrasound images of the heart) to create heart images and make measurements while gradually increasing the Left Ventricular Assist Device (LVAD) heart pump speed. Each time the pump speed is increased, images and measurements are taken. This is called a ramp test.
The ramp testing may also be performed during a right heart catheterization procedure. In a catheterization procedure, a doctor inserts a thin, flexible tube (catheter) into a vein or artery in the upper leg (groin), arm or neck and guides it to the heart using X-ray imaging. Doctors normally perform this procedure to measure the pressure and blood flow in the heart (otherwise called hemodynamic measurements). If the ramp testing is performed during this procedure, then the doctors have additional measurements to consider before choosing a final speed for the Left Ventricular Assist Device (LVAD) pump and appropriate medical treatment.
All of the procedures in this study are considered standard of care. The research part is randomly assigning the subject to one of the two methods of testing in this study. Subjects have a 50/50 chance of being in either testing group.
Baseline Visit (1 - 3 months after Left Ventricular Assist Device (LVAD) implant)
The following will be performed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient older than 18 years
- •Newly implanted HVAD
- •HVAD support anticipated for at least 6 months
- •Patient is ambulatory and discharged from hospital without inotropes
- •Patient is between 1 and 3 months post implant
- •Patient has not had a right heart catheterization since discharged from HVAD implantation hospitalization
排除标准
- •The current HVAD is a replacement device
- •Patients currently has Right Ventricle (RV) failure requiring home inotropes
- •Inability to preformed right heart cath
- •Inadequate echocardiographic windows
结局指标
主要结局
Clinical parameters most likely to be impacted by hemodynamic-echo ramp tests
时间窗: 6 Months
6 Walk Test
New York Heart Association (NYHA) Class
时间窗: 6 Months
Heart Failure Readmission
时间窗: 6 Months
Composite end-point of heart failure readmission.
Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ)
时间窗: 6 Months
Kansas City Cardiomyopathy Questionnaire (KCCQ) a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains in which scores are transformed to a range of 0-100.
次要结局
未报告次要终点