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临床试验/NCT04732039
NCT04732039Unknown不适用

Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Device

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
VO2

研究概览

简要总结

Investigation of oxygen uptake during daily life activities in HF patients with and without LVADs.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Implanted durable left ventricular assist device
  • Age>18yrs
  • Signed informed consent

排除标准

  • No consent
  • Not able to complete VO2 test (physicians decision)

结局指标

主要结局

VO2

时间窗: Stable LVAD recipients on average 2 years after the implantation

Oxygen uptake

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Finn Gustafsson

Professor

Rigshospitalet, Denmark

研究点 (2)

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