Real World Demographic and Clinical Characteristics, Treatment Patterns and Clinical Outcomes of Heart Failure Patients in China: a Retrospective Non-Interventional Nationwide Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60,000
- 试验地点
- 2
- 主要终点
- Patients' demographics at index hospitalization admission.
研究概览
简要总结
This is a non-interventional, multicenter, retrospective study assessing demographic characteristics, clinical characteristics, management and outcome of patients with a HF (heart failure) diagnosis utilizing real world data derived from HF Center Database. This database collects the data of HF from patients hospitalized between March 2010 to Dec 2018 in more than 300 hospitals across China.
详细描述
Research question and objectives Primary objective
- Describe the demographic and clinical characteristics of HF patients at HF index hospitalization admission Secondary objective
- Assess the HF diagnosis and evaluation patterns and treatment patterns during index hospitalization and after discharge compare with guideline (2018 China HF Guideline) recommendations
- Describe the demographic characteristics, clinical characteristics, diagnostic pattern, treatment pattern of HF patients stratified by LVEF (left ventricular ejection fraction) and region Exploratory objectives Describe the demographic and clinical characteristics, sac/val start dose and titration pattern among chronic HF patients prescribed sac/val
Study design This is a non-interventional, multicenter, retrospective study assessing demographic characteristics, clinical characteristics, management and outcome of patients with a HF diagnosis utilizing real world data derived from HF Center Database. This database collects the data of HF from patients hospitalized between March 2010 to Dec 2018 in more than 300 hospitals across China.
Setting and study population This study will include the data from all patients who were enrolled in the HF Center database. The study population consists of adult inhospital patients (18+ years) being diagnosed with HF at discharge.
Inclusion criteria
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Aged 18 years and older
- •Patients with confirmed diagnosis of HF
- •Diagnosis is made by the treating physicians according to local practices and their clinical judgement
排除标准
- •Concomitant participation in any/a clinical trial with any investigational treatment during the index hospitalization
结局指标
主要结局
Patients' demographics at index hospitalization admission.
时间窗: 1 years
Patients' demographics at index hospitalization admission.
Patients' medical history at index hospitalization admission.
时间窗: 1 years
Patients' medical history at index hospitalization admission.
Patients' comorbidities (i.e. diabetes, renal insufficiency, chronic obstructive pulmonary disease, anemia, obesity, hypertension) at index hospitalization admission.
时间窗: 1 years
Patients' comorbidities (i.e. diabetes, renal insufficiency, chronic obstructive pulmonary disease, anemia, obesity, hypertension) at index hospitalization admission.
次要结局
- The percentage of patients who received the guideline (2018 China HF Guideline) recommended tests during the indexed hospitalization.(1 years)
- The percentage of HF patients who received the guideline (2018 China HF Guideline) recommended HFrEF (Hear failure with reduced ejection fraction) pharmacological and device treatments (i.e. ICD, CRT) at the discharge of the index hospitalization.(1 years)
- The percentage of HF patients adherent to guideline.(1 years)
- Follow-up rate at 1month, 3 months and 1 year after discharge from indexed hospitalization.(1 years)
- Outcomes among HF patients stratified by LVEF (<40%/40-49%/≥50%).(1 years)
- Diagnostic pattern comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China.(1 years)
- In-hospital mortality rate at 1month, 3 months and 1 year after discharge from indexed hospitalization.(1 years)
- Re-hospitalization rate at 1month, 3 months and 1 year after discharge from indexed hospitalization.(1 years)
- Diagnostic pattern among HF patients stratified by LVEF (<40%/40-49%/≥50%).(1 years)
- Treatment pattern among HF patients stratified by LVEF (<40%/40-49%/≥50%).(1 years)
- Demographic characteristics among HF patients stratified by LVEF (<40%/40-49%/≥50%).(1 years)
- Medical history among HF patients stratified by LVEF (<40%/40-49%/≥50%).(1 years)
- Demographic characteristics comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China.(1 years)
- Medical history comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China.(1 years)
- Treatment pattern comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China.(1 years)
- Outcomes comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China.(1 years)