Asian Sudden Cardiac Death in Heart Failure (ASIAN-HF) Prospective Observational Registry
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 6
- 主要终点
- Incidence (burden) of Sudden Cardiac Deaths (SCD) in Asian patients with HF followed in a representative setting of Asian cardiology centers
研究概览
简要总结
This is a prospective observational multinational Asian registry of patients with symptomatic Heart Failure (HF) (Stage C) and left ventricular systolic dysfunction (ejection fraction less than 40%) with the broad purpose of determining the mortality (incidence) burden of HF in Asian patients, and more specifically to define the burden and risk factors of SCD, as well as the sociocultural barriers to preventive device therapy. The specific aims of the study are to determine the burden (incidence) of Sudden Cardiac Death (SCD) in Asian patients with Heart Failure (HF) followed in a representative setting of Asian cardiology centers, to determine the risk factors for SCD among Asian patients with HF, to determine the burden and risk factors of outcomes other than SCD (all-cause and cause-specific mortality and hospitalization) and to understand the sociocultural barriers to device therapy among Asian patients.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
This proposed registry is expected to advance fundamental understanding of the burden and predictors of preventable death among Asian patients with HF. The knowledge gained will be critical for guiding resource allocation and planning preventive strategies to address the unmet and growing clinical needs of patients with cardiovascular disease in Asia.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults (more than 18 years) 2.Symptomatic HF (Stage C HF regardless of functional status) Patients should have a current diagnosis of symptomatic HF within 6 months of an episode of decompensated heart failure, which either: •resulted in a hospital admission (primary diagnosis) or •was treated in out-patient clinic 3.Left ventricular systolic dysfunction (ejection fraction less than 40% on baseline echocardiography) 4.Available for follow-up over 3 years.
排除标准
- •1.Severe valve disease as the primary cause of HF 2.Life threatening co-morbidity with life expectancy of less than 1 year 3.Unable or unwilling to give consent 4.Concurrent participation in a clinical therapeutic trial which requires patient consent.
结局指标
主要结局
Incidence (burden) of Sudden Cardiac Deaths (SCD) in Asian patients with HF followed in a representative setting of Asian cardiology centers
时间窗: Baseline Visit up to 3 years (Last Visit/Visit 5)
次要结局
- Risk factors for SCD among Asian patients with Heart Failure(Baseline Visit up to 3 years (Last Visit/Visit 5))
- Burden and risk factors of outcomes other than SCD (all-cause and cause-specific mortality and hospitalization)(Baseline Visit up to 3 years (Last Visit/Visit 5))
- Sociocultural barriers to device therapy among Asian patients(Baseline Visit)