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临床试验/NCT04312802
NCT04312802已完成不适用

Measurement of Cardiopulmonary Exercise Capacity in Patients with Type 1 Diabetes Mellitus Approaching Simultaneous Kidney Pancreas Transplantation

Oxford University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Anaerobic threshold (AT) measurement correlation with cardiac perfusion

研究概览

简要总结

Patients being assessed for Kidney Pancreas transplantation often have pre-existing co-morbid disease that contributes to structural cardiac and vascular disease. There is no consensus on optimal pre-listing cardiac assessment to reliably minimize risk of peri-operative cardiac events. Functional status using the cardio-pulmonary exercise test (CPET) has been used in cardiac and abdominal surgery, including abdominal aortic aneurysm (AAA) repair and kidney transplantation, but high risk patients with diabetes are often lacking from these studies. This study will investigate the correlation between function, measures using CPET and standard cardiac assessment, and determine the variation in usual measures of anaerobic threshold and VO2 max in this population.

详细描述

20 participants will be recruited to a blinded observational study. Patients referred for pancreas kidney transplantation assessment will be provided information about the study. They will subsequently be approached at their initial assessment visit and informed consent will be taken.

Participants will have standard clinical assessment which includes:

  1. Clinical history and examination
  2. 12 lead electrocardiogram (ECG)
  3. Chest X-ray (CXR)
  4. Myocardial perfusion imaging (MPS)
  5. If MPS imaging is suggestive of stress induced ischaemia, or severe left ventricular (LV) dysfunction, the participant will undergo coronary angiography as part of standard assessment protocol.

In addition, study participants will undergo CPET testing. This will take place within 1 week of the standard peri-operative cardiac assessment. The results of this investigation will be recorded against a unique identifier on a secure Oxford University Hospital computer. Information about the study or participants' individual results will not normally be disclosed to the participant or clinical team, and so will not influence clinical management. However if, when the results are analysed, the research team note a CPET result that suggests a clear and significant impairment of functional reserve such that the participant should not be listed, this result will be disclosed to the individual and their medical team so that the information can be used in order to make the safest decision about transplant listing. There will be no further clinical visits but participants will consent to collection of their clinical data until 3 months post-transplant, or until they are removed from the waiting list.

At the end of the study, the results of CPET testing will be correlated to measures from standard cardiac investigations and to peri-operative cardiac events.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is willing and able to give informed consent
  • Diagnosed with type 1 diabetes mellitus with estimated glomerular filtration rate (eGFR)<20ml/min or on renal replacement therapy referred for simultaneous pancreas-kidney (SPK) transplant

排除标准

  • Participant unable to undergo CPET testing due to limitation on mobility or limb movement

结局指标

主要结局

Anaerobic threshold (AT) measurement correlation with cardiac perfusion

时间窗: Single 1 day test

Comparison of AT measurement and MPS imaging result

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

Edward Sharples

Primary Investigator

Oxford University Hospitals NHS Trust

研究点 (1)

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