The First Russian Observational Survey of Heart Failure Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of patients with hospitalization for worsening of heart failure. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment due to HF as the primary reason
研究概览
简要总结
The purpose of this study is to evaluate the management of chronic heart failure patients with atrial fibrillation, to collect data on compliance with clinical guidelines and the prevalence of long-term anticoagulant therapy,complications. The results will be used to develop most rational therapeutic and diagnostic strategies to improve clinical outcomes of such patients.
详细描述
Quality assurance plan: investigators are going to plan site monitoring every three months. Any audits are not planned Investigatirs will check all entered data into the registry with the predefined ranges. The database is protected against any inconsistency and incorrect entering by the strictly predefined range in all fields. Instead of that, data checks will be performed yearly.
During the site monitoring data verification of the transfer from source documents to the database will be performed.
Iiverstigators have data dictionary, which includes descriptions of each variable and, if relevant, normal ranges.
Investigators use standard local operation procedures for any activities during the registry (as patient recruitment, data collection and management, data analysis) and local authorities approve all of those procedures.
Investigators calculated the sample size for demonstration of hypothesis of the registry.
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
- •patient has symptomatic chronic heart failure diagnosed more than 3 months before enrolling, if ejection fraction of left ventricular is >40% - N terminal-pro-B-type natriuretic peptide should be ≥300 pg/ml or B-type natriuretic peptide ≥100 pg/ml.
- •patient has non-valvular stable atrial fibrillation
排除标准
- •transient ischemic attack within 3 days before inclusion,
- •stroke during 14 days before inclusion,
- •myocardial infarction within 14 days before inclusion,
- •thromboembolic complications or thrombosis within 14 days before inclusion,
- •heart failure because of valvular pathology,
- •heart failure induced by infection agents or infiltrative diseases, alcohol consumption, use of psychoactive drugs; peripartal heart failure; transient conditions
- •planning heart transplantation
- •implantation of biventricular pacemaker within 28 days before inclusion
- •any severe condition limiting life less than 3 months
- •HIV infection
- •Alcohol consumption or psychoactive drugs intake
- •participation in any experimental study within 30 days before inclusion
- •patient is not ready to contact by telephone at the end of the study at screening
结局指标
主要结局
Number of patients with hospitalization for worsening of heart failure. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment due to HF as the primary reason
时间窗: Day 1 up to approximately 12 months
次要结局
- All-cause mortality. Death due to any cause.(1 year)
- Death due to a cardiovascular cause. CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV.(Day 1 up to approximately 12 months)
- Bleeding rate. ISTH major or CRNM bleeding during the time the patient is taking the medicine which is 6 months(1 year)
- Rate of thromboembolic events defined as ischemic stroke, system embolism, deep vein thrombosis, pulmonary embolism.(Day 1 up to approximately 12 months)
研究者
Sergey Tereschenko, MD,Phd,prof
Head of department
Federal State Budgetary Scientific Institution, Research Institute of Cardiology