EUCTR2016-000473-20-HR进行中(未招募)1 期
A prospective evaluation of natriuretic peptide based referral of CHF patients in primary care - PREFER
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 1,415
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
入选标准
- •- Willing and able to provide written informed consent and accept study procedures and time schedule.
- •- Age = 18 years.
- •- Patients suffering from chronic heart failure whose diagnosis has been made or confirmed by a cardiologist and/or hospital physician.
- •- Patients with reduced ejection fraction (LVEF = 40%).
- •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 1600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2400
排除标准
- •- Use of investigational drugs within 5 half-lives of enrollment, or within 30 days /until the expected pharmacodynamic effect has returned to baseline.
- •- Major surgery in the last 3 months or planned/foreseeable major surgery or cardiac intervention during the study.
- •- Cancer or other significant co-morbidities implying that the patient’s condition is unstable.
- •- Comorbidities that can be associated with elevated natriuretic peptide (NP) levels, recent (less than 3 months) cerebral trauma or recent (less than 3 months) cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the last 3 months.
- •- Patients who are primarily managed and regularly followed-up by a cardiologist for their HF.
- •- Highly frail patients whose estimated lifespan due to comorbidities is less than 6 months.
研究者
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