NCT03455439已完成不适用
Risk Factors of Outcomes Associated With Disease Progression in Patients With Atrial Fibrillation and Heart Failure (HF) Who Are Receiving a Direct Oral Anticoagulant (Rivaroxaban)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 552
- 试验地点
- 1
- 主要终点
- Time from the baseline visit to the first hospitalization or admission to emergency services due to a Heart Failure exacerbation
研究概览
简要总结
Evaluation of the risk factors associated with Heart Failure (HF) worsening (measured by hospitalizations and emergency visits because of HF exacerbations) in Spanish patients with Atrial Fibrilation and HF treated with rivaroxaban.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females aged 18 years or older.
- •Patients with a diagnosis of nonvalvular Atrial Fibrilation (AF).
- •Patients with a diagnosis of chronic Heart Failure, New York Heart Association (NYHA) class I-IV HF with preserved Ejection Fraction (HFpEF), HF with reduced EF (HFrEF) or HF with mid-range EF (HFmrEF).
- •Patients receiving antithrombotic treatment because of AF, with rivaroxaban since at least 4 months before entering the study.
- •Patients who have been given appropriate information about the study objectives and procedures and with the mental and physical capacity to give their informed consent to participate in the study.
排除标准
- •Patients participating in a research program which involves some intervention beyond clinical practice.
- •Patients who started rivaroxaban after the start of the inclusion period.
- •Patients with significate mitral stenosis or other heart valvular diseases that requires or have needed specific treatment (prosthesis or valvuloplasty).
- •Patients with severe cognitive impairment.
研究组 & 干预措施
Rivaroxaban
Adult patients diagnosed with Atrial Fibrilation and Heart Failure who started treatment with rivaroxaban at least 4 months prior to inclusion
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Time from the baseline visit to the first hospitalization or admission to emergency services due to a Heart Failure exacerbation
时间窗: Up to 24 months or early termination
次要结局
- Date of death(Up to 24 months or early termination)
- Date of all hospitalizations or admissions to emergency service(Up to 24 months or early termination)
研究者
研究点 (1)
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