American Registry of Ambulatory or Acutely Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,732
- 试验地点
- 119
- 主要终点
- Characteristics of population with diagnosis of heart failure in America
研究概览
简要总结
The purpose of this study is to better characterize and understand the population of patients with ambulatory or acutely decompensated heart failure in the American continent, getting to know their sociodemographic, clinical and paraclinical characteristics
详细描述
An observational, prospective and multicenter study in which ambulatory patients with a confirmed diagnosis of heart failure and those admitted to the hospitalization service due to an episode of acutely decompensated heart failure will be invited to participate in order to better characterize this population
Participants who meet the eligibility criteria will be evaluated at the moment of recruitment. Follow-ups will be performed at 1, 6 and 12 months after the initial registry for hospitalized patients. For ambulatory patients follow-up will only be performed at 12 months. These initial evaluations and subsequents follow-ups will be carried out using a standardized form for the collection of hospital and outpatient data through an electronic platform
The purpose of this study is to know sociodemographic, clinical (clinical presentation, hemodynamic profiles, in-hospital and outpatient management, re-hospitalization rate, proportion of mortality, cumulative survival and heart failure readmission-free survival) and paraclinical characteristics of this population
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
- •Patient aged 18 years or older and one of the following:
- •Hospitalized patient with admission diagnosis of acutely decompensated heart failure or
- •Outpatient with confirmed diagnosis (main or complementary) of heart failure
排除标准
- •Hospitalized patient with principal diagnosis of another cardiovascular / non-cardiovascular pathology and who develops an acute decompensation of heart failure during hospitalization.
- •Patient on heart transplant waiting list
- •Patient who has implanted or is in process of implanting a long-term ventricular assist device (eg, Heart Mate II, Heart Mate III) as a target therapy or bridge therapy to other therapies
- •Patient in whom palliative management has been previously defined for his/her cardiac condition (i.e. Heart failure) or for another associated medical condition (cancer, chronic obstructive pulmonary disease (COPD), etc.)
- •Patient who is discharged or referred to another institution within 48 hours of hospital stay
- •Inability to comply with programmed follow-ups (telephone or in person) due to social, personal or other conditions considered by the principal investigator
- •Life expectancy less than 6 months given a condition other than heart failure (Cancer, COPD, etc.)
结局指标
主要结局
Characteristics of population with diagnosis of heart failure in America
时间窗: Baseline, at Month 1, Month 6 and Month 12
Clinical and paraclinical characteristics of patients with heart failure
次要结局
- Outpatient management of heart failure(Baseline and at Month 12)
- Differences among proportion of rehospitalization and heart failure mortality considering implementation of optimal medical treatment(Baseline, Month 1, Month 6 and Month 12)
- Cumulative heart failure survival and readmission-free survival(Baseline, Month 1, Month 6 and Month 12)
- In-hospital management of acutely decompensated heart failure(Baseline)
- Relation between outpatient pharmacological treatment with proportion of hospitalization and mortality at 1, 6, 12 months after hospital discharge(Month 1, Month 6 and Month 12)
- Differences among proportion of rehospitalization and heart failure mortality considering sociodemographic characteristics(Baseline)
- Clinical and hemodynamic presentation of acutely decompensated heart failure(Baseline)
- Proportion of in-hospital mortality related with acute decompensation of heart failure(Baseline)
- Relation between hemodynamic profile of decompensation with proportion of mortality at 1, 6, 12 months after hospital discharge(Baseline, Month 1, Month 6 and Month 12)
- Differences among hospitalization and heart failure mortality considering the use of cardiac devices(Baseline, Month 1, Month 6 and Month 12)
- Relation between outpatient treatment of heart failure with proportion of hospitalization and mortality(Baseline and at Month 12)
- Proportion of rehospitalization at 1, 6, 12 months after hospital discharge(Month 1, Month 6 and Month 12)
- Relation between in-hospital pharmacological treatment with mortality at 1, 6, 12 months after hospital discharge(Month 1, Month 6 and Month 12)
- Proportion of mortality at 1, 6, 12 months after hospital discharge(Month 1, Month 6 and Month 12)
- Relation between in-hospital pharmacological treatment with proportion of readmissions at 1, 6, 12 months after hospital discharge(Month 1, Month 6 and Month 12)
- Differences among heart failure treatment considering sociodemographic characteristics(Baseline)
研究者
Juan Esteban Gomez
Chief of the Cardiology Department
Fundacion Clinica Valle del Lili