NCT00143793已完成不适用
Mannheim NT-proBNP Study (MANPRO) Evaluating NT-proBNP and New Biomarkers in Patients Suffering From Dyspnea and/or Peripheral Edema for the Differential Diagnosis of Congestive Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
研究概览
简要总结
The objectives of this study are to:
- Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure in patients with acute dyspnea and/or edema.
- Determine the exact biomarker cut-off point(s) for the differentiation of healthy persons, patients with heart failure and patients with dyspnea of other origin.
- Evaluate treatment costs in patients with dyspnea under special consideration of NT-proBNP measurement.
详细描述
Primary endpoint:
- Sensitivity and specificity of biomarker measurements for discrimination of heart failure from dyspnea of other origin.
Secondary endpoints:
- Determination of Cut-off(s)
- Discrimination of cardiac and non-cardiac diseases causing to dyspnea or peripheral edema
- Determination of treatment costs of the initial hospital stay
- Evaluation of resource savings when implementing NT-proBNP for determination of diagnosis.
- Time to diagnosis.
- Hospitalization rate /Intensive care treatment rate between day 1 and 28
- Duration of initial hospital stay
- 30-day re-hospitalization rate
- 30 day mortality rate and adverse event rate
- 1 and 5 year mortality rates
- 1 and 5 year rehospitalization rates
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90 years
- •Dyspnea or/and peripheral edema
- •Informed consent
排除标准
- •Renal insufficiency with creatinine > 2.8mg/dl
- •Anemia (hemoglobin < 8.0mg/dl)
- •Pregnancy
研究者
Michael Behnes
Dr. med.
Universitätsmedizin Mannheim
研究点 (1)
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