Cohort Study of Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- incidence of composite event (cardiovascular mortality, unplanned HF hospitalization, emergency HF intervention)
研究概览
简要总结
The goal of this observational study is to learn about the influencing factors of chronic heart failure prognosis in heart failure patients. The main question it aims to answer is that what are the influencing factors of clinical outcomes in chronic heart failure. Participants will be collected multiple omics data such as phenotype group, environmental exposure group, intestinal microbiome, genome, metabolome, and noninvasive biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥18 years;
- •Fulfill at least one of the following criteria：①History of chronic heart failure;②New-onset heart failure with LVEF <50%；③New-onset heart failure with LVEF≧50%，E/e'≧15 and BNP>400 pg/mL/NT-proBNP(<50 years, >450 pg/mL; 50~75 years, >900 pg/mL; >75 years, >1800 pg/mL)
- •Etiology: dilated cardiomyopathy, hypertensive heart disease, ischaemic cardiomyopathy, Non-severe valvular heart disease；
- •Primary post-discharge therapy: oral medication;
- •Sign the informed consent form.
排除标准
- •Patients with renal failure (Ccr<30ml/min) or patients on dialysis therapy;
- •Various correctable secondary causes of cardiac insufficiency including hyperthyroid heart disease, anaemic heart disease, uncorrected congenital heart disease; severe valvular heart disease (including severe stenosis or closure of organic aortic and mitral valves);
- •Patients with indications for pacemaker implantation but have not received a pacemaker implant;
- •Patients with chronic obstructive pulmonary disease accompanied by type II respiratory failure.
- •Patients who cannot understand and sign an informed consent form.
- •Patients with mental illness, pregnant women, and other special populations.
研究组 & 干预措施
Routine management group
Remote home management group assisted by community physicians
干预措施: Remote monitoring assisted by community physicians (Behavioral)
结局指标
主要结局
incidence of composite event (cardiovascular mortality, unplanned HF hospitalization, emergency HF intervention)
时间窗: 2 years
Cardiovascular disease death, heart failure readmission and emergency HF intervention are three endpoint events, with either occurring as the primary endpoint
次要结局
- all-cause mortality(2 years)
研究者
Ming Chu
The deputy dean of the hospital
Jiangsu Taizhou People's Hospital