The Helios Heart Registry: A Standardized Registry for Capturing Clinical and Patient-reported Outcomes in Patients With Specific Cardiac Diseases: Application of the ICHOM Standard in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24,000
- 试验地点
- 10
- 主要终点
- All-cause mortality during f/u
研究概览
简要总结
Investigator-initiated, prospective, non-randomized, open label, non-interventional multicenter registry to evaluate current treatment of three major cardiovascular disease entities in clinical practice using a standardized variable-set of relevant covariates and outcome measures.
详细描述
Heart failure (HF), coronary artery disease (CAD) and atrial fibrillation (AF) are among the most relevant cardiovascular diseases contributing to overall morbidity and mortality each itself and in particular in case of their coexistence. Several new therapies have been introduced in randomized controlled trials but confirmation data of treatment effects in real-world cohorts using a standardized methodology is scarce. The International Consortium for Health Outcomes Measurement (ICHOM) defined standard variable sets for all three diseases in order to objectively monitor the course of disease.
To evaluate current health care utilization and interactions between diseases and treatments in patients with HF, CAD and AF as well as patient-oriented values study initiator will build a prospective, observational, multicenter cardiovascular registry using standardized patient variables and endpoints based on the ICHOM recommendations.
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
- •Age of 18 years or older
- •Inpatient Treatment
- •Present diagnosis of at least one of the three cardiovascular disease entities of interest according to the current guidelines of the European Society of Cardiology (ESC): HF, CAD, AF
排除标准
- •Inability to provide informed consent
- •Initial presentation (index hospitalization) in cardiogenic shock or other kinds of shock
- •Patient after heart transplantation or patient with present ventricular assist device (VAD)
结局指标
主要结局
All-cause mortality during f/u
时间窗: 18 months
次要结局
- general quality of life (PHQ2)(18 months)
- rate of rehospitalizations for cardiovascular causes during f/u(18 months)
- cardiovascular mortality during f/u(18 months)
- length of hospital stay(3 days)
- disease specific quality of life (KCCQ-12 [HF])(18 months)
- disease specific quality of life (SAQ-7 [CAD])(18 months)
- rate of rehospitalizations of any cause during f/u(18 months)
- general quality of life (PROMIS)(18 months)
- disease specific quality of life (AFEQT [AF])(18 months)
- complications associated with therapeutic interventions(18 months)
- in-hospital mortality(3 days)
- rate of rehospitalizations for specific cardiovascular diseases(18 months)
- rate of specific cardiovascular events(18 months)
- side effects associated with drug treatment(18 months)
- disease associated treatment costs(18 months)
- adherence to therapy(18 months)