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临床试验/NCT02658136
NCT02658136已完成不适用

Computed Tomography Estimated Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices

Finn Gustafsson2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Peak Oxygen Uptake

研究概览

简要总结

Exercise capacity in continous-flow left ventricular assist device (CF-LVAD) patients remains severely reduced post-implant. While the effect of right ventricular (RV) failure early after pump implantation, and its effect on outcome has been extensively studied, the effects of late RV failure on exercise capacity and quality of life (QOL) has been sparsely described. Thus the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.

详细描述

When pharmacological therapy becomes insufficient in advanced end-stage heart failure (HF) transplantation remains the gold standard of therapies. However, due to a severe lack of donor organs, mechanical circulatory support is an alternative option for some eligible patients. Mechanical circulatory support in the form of a CF-LVAD is a pump supporting the left ventricle by pumping blood from the apex to the ascending aortae. Implantation with a CF-LVAD increases survival and improves quality of life, but peak oxygen uptake (peak VO2) remains severely reduced post-implant. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance. Furthermore a fixed CF-LVAD pump speed prevents adequate circulatory support during strenuous exercise. The effects of late right ventricular (RV) failure on exercise capacity and quality of life (QOL) is, however, unknown and the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Outpatients from Department of Cardiology, Rigshospitalet, Denmark.
  • Age ≥ 18 years.
  • Ischemic or non-ischemic cardiomyopathy.
  • Signed informed consent.

排除标准

  • Unstable patients with the need for intravenous inotropic therapy.
  • CF-LVAD implantation less than one month ago.
  • eGFR < 45 ml/min.
  • Contrast allergy.

结局指标

主要结局

Peak Oxygen Uptake

时间窗: Day 1

Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min.

次要结局

  • Right Ventricular Function (RVEF) During Exercise(Day 1)

研究者

发起方
Finn Gustafsson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Finn Gustafsson

MD; PhD

Rigshospitalet, Denmark

研究点 (2)

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