Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in Implantable Cardioverter-defibrillator (ICD) Therapy (BIOMARKERICD)
Evaluation of Novel Biomarkers to Improve Risk Stratification and Patient Selection in ICD Therapy
Implantable cardioverter-defibrillator (ICD) therapy reduces mortality in patients with chronic heart failure and reduced left ventricular ejection fraction (LVEF) <36%. Nevertheless, patient selection for ICD therapy based on LVEF and NYHA functional class alone seems to have a low specificity and sensitivity: In 100 patients treated, the SCD-HeFT study prevented 7 deaths in 5 years. Therefore 93 patients have a risk of adverse effects, such as operation risk, infection, pneumothorax, lead dislocation, and inadequate icd therapy. On the other hand, patients with advanced or end stage heart failure might rather die off progressive heart failure death and thus not benefit from ICD therapy.
It therefore seems appropriate and necessary to improve the individualized risk stratification in these patients. The aim of this study is to evaluate multiple cardiac biomarkers in a model predicting ventricular arrhythmias in patients on ICD therapy.
研究概览
详细说明
研究类型
注册 (预期的)
联系人和位置
学习地点
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-
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Hannover、德国、30625
- Hannover Medical School
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patient meeting the current indications for primary or secondary prophylactic ICD/CRT-D therapy
- age 18 years or older
Exclusion Criteria:
- Patient unwilling to participate.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ICD therapy
大体时间:2 years
|
ICD therapy (ATP/Shock) for ventricular fibrillation/ventricular tachycardia or inadequate therapy for supraventricular tachycardia/oversensing/lead dysfunction
|
2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life
大体时间:2 years
|
MLWHFQ, EQ5D
|
2 years
|
|
Depression scale
大体时间:2 years
|
PHQ-9
|
2 years
|
|
6-Minute-walk-test
大体时间:6 months
|
6-Minute-walk-test
|
6 months
|
|
all-cause mortality
大体时间:2 years
|
All-cause mortality
|
2 years
|
|
Heart Failure Events
大体时间:2 years
|
Changes in NYHA classification, Hospitalizations
|
2 years
|
|
Risc Scores for Heart Failure events/ICD therapy
大体时间:2 years
|
Seattle Heart Failure Model, Lee-Score, PROFIT-Score
|
2 years
|
合作者和调查者
调查人员
- 首席研究员:David Duncker, MD、Hannover Medical School
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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