China Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Prospective Study of Patients With Heart Failure (HF)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
The investigators will consecutively recruit 5000 patients hospitalized for heart failure (HF) from 50 hospitals across China and follow them up for one year, describe treatment patterns during hospitalization and the follow-ups, examine patients recovery trajectory after HF, and identify targets for care quality improvement.
详细描述
This study will consecutively enroll patients with HF as the primary reason for hospitalization in 50 hospitals scattered all over China. Participants will be interviewed at baseline (i.e., during the index hospitalization for HF), and at 1, 6, and 12 months following hospital discharge. During the follow-up period, participants will be instructed to return to the hospital for interviews by site investigators. Telephone follow-ups will be conducted only when in-person interviews are not feasible.
At baseline, participants will be interviewed to collect detailed information about on demographics, socioeconomic status, cardiovascular risk factors, clinical characteristics, treatments, in-hospital outcomes, general and disease-specific quality of life, function and mental status; during the follow-ups, the investigators will collect information about clinical outcomes events, long-term treatments, function, quality of life, symptoms, and medical care during the recovery period.
The investigators will collect blood and urine samples during index hospitalization and the follow-ups.
This study will examine a series of factors that may affect patients' recovery after HF. Practical guidelines, quality evaluative system, and risk model will be established based on the findings, to improve patient outcomes in the future.
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
- •Patients with heart failure as the primary reason for hospitalization, including both new-onset HF or decompensation of chronic HF
- •Aged 18 years or above
排除标准
- •Patients who have enrolled in this study
- •Patients who usually do not live in the city/county where the index hospital locates
- •Patients who are unable to complete interviews due to severe conditions, mental illness, or communication difficulties.
结局指标
主要结局
Major adverse cardiac events
时间窗: 1 year
Major adverse cardiac events is defined as the composite of cardiovascular death, resuscitated sudden death, HF-related rehospitalization, myocardial infarction, stroke, and incident atrial fibrillation.
次要结局
- Myocardial infarction(1 year)
- Incident atrial fibrillation(1 year)
- Rehospitalization(1 year)
- Quality of life for HF (KCCQ-12)(1 year)
- Function of cognition (Mini-cog)(1 year)
- Incident renal insufficiency(1 year)
- Anxiety (GAD-2)(1 year)
- Stroke(1 year)
- Quality of life (EQ-5D)(1 year)
- Stress (PSS-4)(1 year)
- Death(1 year)
- Resuscitated sudden death(1 year)
- Depression (PHQ-8)(1 year)
