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临床试验/NCT04293471
NCT04293471招募中不适用

Prediction of Heart-failure and Mortality by Echocardiographic Parameters and Machine Learning in Individuals With Left Bundle Branch Block

University Hospital of North Norway1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Death of any cause

研究概览

简要总结

Patients with left bundle branch block have an increased risk for the development of heart-failure and death. However, risk factors for unfavorable outcomes are still poorly defined. This study aims to identify echocardiographic parameters and ECG characteristics by machine learning in order to develop individual risk assessment

详细描述

The project investigates patients with left bundle branch block (LBBB) which describes a specific block in the electrical conduction system, where the electrical impulses must follow a detour, with the result that different parts of the heart-muscle do not contract at the same time. This condition is called left ventricular dyssynchrony. LBBB can be found in people who are otherwise completely healthy and need not have any practical consequences. In others LBBB is present in patients with different heart diseases such as after myocardial infarctions or other diseases involving the heart-muscle. Patients with implanted pacemakers have a similar failure in the conduction system. Both conditions can increase the risk for development of heart-failure and cardiovascular death. Dyssynchrony can be treated with a special pacemaker (cardiac resynchronisation therapy, CRT) in addition to regular medical treatment. The therapy is well established and has shown to reduce morbidity and mortality and even reverse heart-failure in some patients completely. However, the patients in need and responding to CRT treatment is still not optimally defined. New echocardiographic parameters based on strain imaging such as regional myocardial work are able quantify the degree of dyssynchrony and give new insights into the interplay of activation delay through the LBBB and loading conditions and weakness of the myocardium due to other diseases. These new and complex measures can be integrated with clinical information by machine learning (ML) as a promising tools for accurate patient selection for CRT. The project aims to find markers on ultrasound improved by ML based selection to distinguish those patients who have problems associated with the branch block from those who remain stable. This will facilitate both, an optimized patient selection for CRT treatment and follow-up schedule for those who have a stable condition.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • QRS complex >130 ms and R-wave duration in
  • V6 >70 ms
  • ventricular pacing>50%
  • Previously implanted cardiac resynchronisation therapy (CRT)

排除标准

  • Typical right bundle branch block.
  • No ability to give informed consent,
  • non-cardiovascular co-mobidities with reduced life-expectancy < 1 year
  • patients with complex congenital heart disease.

结局指标

主要结局

Death of any cause

时间窗: 15 years

Timepoint (day) of death and its cause

Cardiovascular death

时间窗: 15 years

Timepoint (day) of death and its cause

次要结局

  • Hospital admission due to heart-failure(15 years)

研究者

发起方
University Hospital of North Norway
申办方类型
Other
责任方
Principal Investigator
主要研究者

Assami Rosner

MD PhD

University Hospital of North Norway

研究点 (1)

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