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临床试验/NCT02493907
NCT02493907Unknown不适用

A Prospective Clinical Trial of Corrected Left Ventricular Electrical Delay Predicting Response to Cardiac Resynchronization Therapy in Chinese With Heart Failure

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Left Ventricular End Systolic Volume (LVESV)

研究概览

简要总结

Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with severe systolic heart failure (HF) and ventricular desynchronization. Despite the consistently observed structural and functional improvements as well as reductions in HF events and mortality in large multicenter randomized trials, 30% patients remain classified as nonresponders. Present evidences showed that QRS duration was the most effective parameter to predict responsivity of CRT in patients with severe HF. But some studies showed that QRS duration could be influenced by obesity and gender. Accordingly, the simple QRS interval width of body surface electrocardiograph should not be the most satisfactory parameter for screening patients suitable for CRT. Recent study showed that left ventricular electrical delay, as measured by the time from the onset of QRS to the LV electrogram peak (QLV), predicted CRT response. At long QLV intervals, atrioventricular optimization (AVO) can increase the likelihood of structural response to CRT. However, it is unclear whether it is suitable for Chinese patients. The investigators would like to validate this relation in a Chinese population and explore if a corrected QLV might do better to predict the responsivity of CRT.

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

入选标准

  • •More than 18 Years
  • Informed consent signed
  • NYHA class ≥ II, an ejection fraction of ≤ 0.35, QRS duration of ≥ 150 milliseconds with Non-LBBB) or ≥ 120 milliseconds with LBBB, who treated with CRT
  • The Estimated survival time was more than one year
  • sinus rhythm, pacemaker independent

排除标准

  • •NYHA class I symptoms
  • Severe liver or kidney dysfunction
  • Valvular heart disease
  • Pregnancy or lactation women
  • percutaneous coronary intervention (PCI) or cardiac artery bypass graft (CABG) within 3 month
  • Have malignant tumors and the Estimated survival time was less than one year
  • an enzyme-positive myocardial infarction within 3 months before enrollment, or atrial fibrillation
  • any reasons cannot complete follow-up; Or researchers think that don't suit to be included in the research of other conditions

结局指标

主要结局

Left Ventricular End Systolic Volume (LVESV)

时间窗: baseline and 6 months

change in LVESV

次要结局

  • left ventricular ejection fraction (LVEF)(baseline and 6 months)
  • New York Heart Association (NYHA)(baseline and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingfeng Wang

subdecanal

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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