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临床试验/NCT02396875
NCT02396875Unknown不适用

Selective Coronary Vein Sampling in Dyssynchronous Heart Failure and Cardiac Resynchronisation Therapy to Assess Physiological Response to Exercise and Characterise Regional Release of Novel Biomarkers

Guy's and St Thomas' NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
试验地点
2
主要终点
Levels of Various biomarkers measured from different coronary veins at rest and following exertion both pre CRT implant and at 6 months

研究概览

简要总结

Cardiac resynchronisation therapy (CRT) prolongs the life and improves the symptoms in patients with heart failure and electrical dyssynchrony. 30-50% of patients do not improve with the treatment which is both expensive and not without complication. Despite much research, we cannot accurately predict who will not respond. Furthermore, most heart failure patients gets symptoms on exercise and most studies have examined patients at rest. We propose to investigate the effect of exercise on different parts of the left ventricle by sampling various biomarkers of metabolism, myocardial injury and gene expression. We will then repeat the protocol following device insertion to look for changes. This novel work will require a small cohort of patients with heart failure and no electrical dyssynchrony and normal patients to act as controls. We will also measure novel biomarkers at different venous sites relating to different parts of the myocardium to determine whether they can be used to prognosticate or even predict response to CRT.

详细描述

We propose to examine the acute effects of exercise on patients with dyssynchronous electrical activation of the heart and heart failure and to compare the release of novel biomarkers in selective areas of coronary venous drainage by direct cannulation of different veins via the coronary sinus (CS).

The study design will separate patients into a minimally invasive arm (MINARM)and an invasive arm (INARM). The INARM will be recruited from patients in the MINARM.

MINARM

Group 1: 40 patients scheduled for CRT implant Group 2: 15 patients with heart failure and no dyssynchrony Group 3: 15 patients with normal hearts

Group 1:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Scheduled for CRT implant
  • Group 2/B -Heart failure without electrical dyssynchrony.
  • Scheduled for angiography for clinical grounds
  • Group 3/C -Patients without known heart disease
  • Scheduled for clinical angiography and found to have normal coronary arteries

排除标准

  • Pregnancy
  • Moderate to severe aortic valve disease

结局指标

主要结局

Levels of Various biomarkers measured from different coronary veins at rest and following exertion both pre CRT implant and at 6 months

时间窗: 2 years

Biomarkers and metabolites to be assessed include but are not limited to O2, lactate, glucose, CKMB, hs trop, galectin3, Soluble St2, Nt proBNP, cardiac myosin binding protein C, 10 different micro RNA associated with myocardial stress/damage

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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