CHaracterization Of the STate of the System of Care for Patients With Chronic Heart Failure in the Regions of the Russian Federation: Identification, Diagnostics, Treatment, Observation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20,000
- 试验地点
- 2
- 主要终点
- Age of subjects with different phenotypes and stages of CHF
研究概览
简要总结
A prospective-retrospective observational registry of patients diagnosed with chronic heart failure in the regions of the Russian Federation.
The study is non-interventional and does not involve any interventions in clinical practice, the choice of treatment methods (including the type of medical device used and the method of surgical intervention) and examination.
A control observation group is not intended.
详细描述
The study will include retrospective and prospective data of patients with an outpatient or inpatient diagnosis of CHF.
The duration of the observation period of an individual patient with CHF is limited by the study period, or the patient's death, and includes the studied retrospective and dynamic prospective parameters. Prospective data of CHF (any stage and FC) subjects are planned to be included sequentially as they appear in inpatient CHF centers and outpatient CHF offices until 12/31/2027 inclusive and further upon extension of the study.
Retrospective data will be provided by chief freelance cardiologists of 33 constituent entities of the Russian Federation (Central Federal District, Ural Federal District, Siberian Federal District, Far Eastern Federal District) (individually, according to agreement)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Any stage and/or any class of CHF
排除标准
- •Subjects whose source records cant be obtained for the analysis
结局指标
主要结局
Age of subjects with different phenotypes and stages of CHF
时间窗: Every 12 months, up to 3 years
Female to male sex ratio of subjects with different phenotypes and stages of CHF
时间窗: Every 12 months, up to 3 years
Clinical status of subjects with different phenotypes and stages of CHF
时间窗: Every 12 months, up to 3 years
Proportion of employable and working subjects with different phenotypes and stages of CHF
时间窗: Every 12 months, up to 3 years
The proportion of subjects with different algorithms for diagnosing CHF and the proportion of subjects with a verified diagnosis of CHF (established according to the recommended algorithm for diagnosing CHF)
时间窗: Every 12 months, up to 3 years
The proportion of subjects taking drugs of each class and all four classes of the recommended four-component therapy regimen (in the overall choice and in different phenotypes of CHF; working/non-working age; working/non-working)
时间窗: Every 12 months, up to 3 years
Number and proportion of subjects with wearable devices when using an online tool for identifying subjects with CHF with indications for high-tech medical care
时间窗: Every 12 months, up to 3 years
Number and proportion of subjects when using an online tool for identifying subjects with CHF with indications for high-tech medical care
时间窗: Every 12 months, up to 3 years
次要结局
- Proportions of subjects with an increase in EF ≥10% and a decrease in the functional class of CHF by 1 point(Every 12 months, up to 3 years)
- The proportion of subjects hospitalized for decompensated CHF in the departments of therapeutic and cardiology profiles *(Every 12 months, up to 3 years)
- Proportion of subjects with newly diagnosed type 2 diabetes*(Every 12 months)
- Proportion of subjects with deterioration of renal function*(Every 12 months, up to 3 years)
- Proportion of subjects with newly diagnosed malignant neoplasm*(Every 12 months, up to 3 years)
- Proportion of subjects who died from CV causes*(Every 12 months, up to 3 years)
- Proportion of subjects with different causes of death*(Every 12 months, up to 3 years)
- Incidence and event rates (per 100 subject-years) for hospitalizations due to HF*(Every 12 months, up to 3 years)
- Incidence and event rates (per 100 subject-years) for death from CV causes*(Every 12 months, up to 3 years)
- Incidence and event rates (per 100 subject-years) for death from any cause*(Every 12 months, up to 3 years)
- The proportion of subjects with preferential drug provision for cardiovascular disease, diabetes mellitus*(Every 12 months, up to 3 years)
- Average frequency of outpatient visits of subjects with CHF to medical institutions*(Every 12 months, up to 3 years)
- The proportion of subjects registered with a cardiologist or therapist with different phenotypes and stages of CHF*(Every 12 months, up to 3 years)
- Average frequency of telephone patronage *(Every 12 months, up to 3 years)