Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Devices (Act-VAD)
Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Device
研究概览
详细说明
In patients with terminal HF the gold standard for treatment is heart transplantation, though the Worldwide shortage of donor organs has led to increased use of implantable mechanical circulatory support devices. The treatment with implantable pumps in the form of a Continuous Flow Left Ventricular Assist Device (CF-LVAD, or simply LVAD) is extremely effective for a selected patient groups leading to significant improvement in survival and quality of life.
The device is a battery-powered flow pump that carries the blood from the left ventricle to the main artery, via a cannula, and thus relieves the failing left ventricle with up to 10 liters of blood per minute. An LVAD can be used both as lifelong support therapy (Destination Therapy, DT) or until transplantation can take place (Bridge therapy).
As patients today live for more than 10 years with the device as DT, the focus has shifted from mere survival to quality of life and physical ability.
In recent years, our research group showed that the pump speed and the patient's baseline heart rhythm (sinus rhythm vs atrial fibrillation) and reduced ability to regulate the intrinsic rhythm after implantation (chronotropic incompetence) are significant contributors to the reduced exercise capacity seen in this patient group.
Until now, studies have elucidated the work capacity of this patient group using a 6-minute walk test or bicycle test - none of these reflect how well the patient actually functions in his everyday life.
In this study, we will describe oxygen uptake related to specific daily activities (ADL-VO2) and compare these with the well-known maximum work capacity (percentage of expected oxygen uptake / pVO2) in this patient group.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Kiran K Mirza, MD
- 电话号码:+4535451442
- 邮箱:KMIR0003@regionh.dk
研究联系人备份
- 姓名:Finn Gustafsson, MD, PhD, DMSci
- 电话号码:004535459743
- 邮箱:finn.gustafsson@regionh.dk
学习地点
-
-
DK
-
Copenhagen、DK、丹麦、2100
- 招聘中
- Rigshospitalet
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
LVADs:
Inclusion Criteria:
- Implanted durable left ventricular assist device
- Age>18yrs
- Signed informed consent
Exclusion Criteria:
- No consent
- Not able to complete VO2 test (physicians decision)
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:LVAD recipients
Peak oxygen uptake vs VO2 measure during specific daily life activities in LVAD recipients
|
Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).
|
|
实验性的:Healthy controls
Peak oxygen uptake vs VO2 measure during specific daily life activities in healthy controls.
|
Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
VO2
大体时间:Stable LVAD recipients on average 2 years after the implantation
|
Oxygen uptake
|
Stable LVAD recipients on average 2 years after the implantation
|
合作者和调查者
调查人员
- 首席研究员:Finn Gustafsson, MD,PhD,DMSci、Rigshospitalet, Denmark
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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