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临床试验/NCT01315223
NCT01315223Unknown3 期

Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)

Hillel Yaffe Medical Center2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
3 期
入组人数
300
试验地点
2
主要终点
Reduction of hospitalization for acute heart failure

研究概览

简要总结

Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure (AHF) several times a year. Currently, we have no method for prediction of future developments of AHF. In our center we have investigated the monitoring of lung impedence as a predictor for future deterioration. It was found that a decrease in lung impedence of more than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we try to prove the hypothesis that preventive treatment according to lung impedence value may prevent future hospitalizations for AHF and improve clinical outcome.

Patients recruited by year:

2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Patients suffering from CHF, NYHA II-IV class
  • LV lower than 35% to LV lower than 45%

排除标准

  • Patients with additional disease with life-expectancy of less than 2 years

结局指标

主要结局

Reduction of hospitalization for acute heart failure

时间窗: Five years

次要结局

  • Improved clinical outcome for CHF patients(Five years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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