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临床试验/NCT03096678
NCT03096678招募中不适用

Morphological and Functional Changes, Risk Stratification and Prognosis of Patients With Compete Left Bundle Branch Block

Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年1月1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
500
试验地点
1
主要终点
All-cause death

研究概览

简要总结

The investigators sought to evaluate the morphological and functional changes, risk stratification and prognosis of patients of participants with compete left bundle branch block (CLBBB).

The conduction of this study was largely due to the increased clinical requirement, which reflected the increased awareness among physicians of heart failure due to asynchronous cardiac function caused by CLBBB. The investigators also aim to figure out the time point or CMR parameters for cardiac resynchronization therapy in patients with CLBBB.

详细描述

The effect of cardiac resynchronization therapy (CRT) for heart failure patients was heterogeneous. Candidate selection was important before intervention. The underlying mechanical dyssynchrony of left ventricular bundle branch block was insufficiently descripted. Earlier study of investigators found novel imaging methods such as cardiovascular magnetic resonance imaging including T1 Mapping and feature tracking imaging can provide more detailed information about regional and global LV function in patients. While the role of new cardiac MR imaging techniques in predicting CRT responses, especially in LBBB patients, is still insufficient. Z Chen et al used T1 mapping technique to quantitatively assess the diffuse fibrosis burden of myocardial in heart failure patients. But they found focal fibrosis burden, not diffuse burden, is associated with a poor response to CRT. Other cardiac MR imaging parameters also showed potential predictors of CRT, such as 16 segment time-to-maximum radial wall thickness , scar locations and RV septal lead placement.In this study cardiovascular magnetic resonance imaging (including T1 Mapping combined with feature tracking imaging ) will be applied to follow up LV function in LBBB patients (with or without intervention) in 10 years to find out prognostic predictors and time point or CMR parameters for cardiac resynchronization therapy in patients with CLBBB.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subject is 18 years or older and able and willing to consent.
  • The patient should present a complete left bundle branch block (LBBB) with QRS duration of >120ms
  • The patients should be in NYHA functional class I, II or III.

排除标准

  • No informed consent
  • Permanent atrial fibrillation, flutter or tachycardia (>100 bpm).
  • Right bundle branch block
  • Recent myocardial infarction, within 40 days prior to enrolment.
  • Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days.
  • Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year.
  • Severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period).
  • Complex and uncorrected congenital heart disease.
  • Claustrophobia or devices

结局指标

主要结局

All-cause death

时间窗: 10 years

Heart Transplantation

时间窗: 10 years

Cardiovascular death

时间窗: 10 years

次要结局

  • Hospitalization due to heart failure(10 years)
  • Myocardial Infarction(10 years)
  • Stroke(10 years)
  • ICD Implantation(10 years)
  • Pacemaker Implantation(10 years)

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Minjie Lu

Principal Investigator

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (1)

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