EUCTR2006-001259-36-SE进行中（未招募）不适用
A randomised, parallel group, single blind, multicentre, 9-month, phase IV study in a primary care setting, comparing treatment guided by clinical symptoms and signs and NT-proBNP vs treatment guided by clinical symptoms and signs alone, in patients with heart failure and left ventricular systolic dysfunction. - SIGNAL HF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of informed consent.
- •2. Female or male, aged 18 years and over
- •3. Diagnosis of heart failure with previously verified left ventricular systolic dysfunction, stated as at least mildly impaired and/or ejection fraction (EF) < 50%.
- •4. NYHA class II-IV
- •5. Plasma NT-proBNP: males >800 ng/L, females >1000 ng/L
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Planned CV hospitalisation (eg cardiac surgery) within the study period.
- •2. Stroke, acute myocardial infarction or open heart surgery within the last 3 months before enrolment.
- •3. Mitral stenosis, aortic stenosis of clinical significance.
- •4. Patients already receiving optimal heart failure treatment according to the national guidelines.
- •5 Pregnancy or lactation.
- •6. Severe medical condition, other than disease under investigation, with life expectancy less than 9 months.
- •7. Severe reduction of kidney function, serum-creatinine >265 umol/L.
- •8. Suspected poor capability to follow instructions of the study
- •9. Previous participation in the present study
- •10. Participation in a clinical study during the last 30 days.
研究者
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