Heart Failure STratification and OutcomeS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Background: Heart failure (HF) is in many cases the final way for coronary heart diseases. In older than 65 years is the most important cause of hospitalization. Many studies have analyzed the causes of decompensation and the possible causes of hospital re-admission but most evidences come from the hospital setting. Nevertheless, It is known that many of these patients are usually attended in primary care setting, being treated by their General Practitioner and are not referred to the hospital.
The determinants which condition whether stable HF patients will be hospitalized as a consequence of a decompensation remain still unclear.
Objective: To develop and validate a predictive model based on clinical variables easy to measure at primary care to predict short-term hospitalization or mortality in a cohort of patients attended in primary care setting as a consequence of a HF decompensation.
Methods: A cohort of patients with established HF attended in primary care setting (regular care or out of hours) as a consequence of an episode of HF decompensation will be follow up. To develop the predictive model we will select variables which previously have been found involved in the risk of hospitalization or mortality as a consequence of HF as well as other ones which could be relevant and have not been studied yet. Variables selected should be easily determined in primary care setting..
The predictive model obtained in the derivation cohort from Spain will be validated in an external (several European countries) validation cohort.
Relevance: Our study will help GP to identify HF patients at higher risk of hospitalization or death and manage them according to an accurate prognostic rule (escala pronostica) made in primary care setting.[DISCUTIR]
详细描述
DESIGN:
Multicenter prospective cohort study in which patients diagnosed of Heart Failure and suffering from a clinical decompensation will be followed for a 30 days in order to predict short-term hospitalització or mortality.
SETTING:
- Derivation cohort will consist of HF patients recruited in more than 20 general practices settled in the city of Barcelona.
- Internal validation cohort: population recruited will come from the same general practices than derivation cohort.
- External Validation population will come from the rest of European countries participants.
Since the health system could be different in the participant countries we will consider as a primary care all consultations attended by General Practitioners out of the hospital setting (which includes out of hours clinics managed by GP).
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 45 or more with previous diagnoses of HF in its medical record and a decompensation of HF treated/attended in primary care settings at the moment of the inclusion.
- •Decompensation is defined as the presence of at least one of the following clinical conditions (12):
- •The worsening functional class according to the criteria of the New York Heart Association (NYHA).
- •A weight gain of more than one kilogram in a period of 24 hours or greater than two kilograms in a maximum of 72 hours.
- •Increased ankle edema (self-reported by the patient, caregiver or physician)
排除标准
- •Patients with severe psychiatric illness or severe cognitive impairment, not able to complete the study protocol.
- •Refusal to participate in the study.
- •Patients directly attended in the hospital in the previous 30 days.
- •Every patient will be followed up to 30 days after the decompensation episode. We are intended to consecutively including patients in the study during a period of two years, from December 2014 to December 2016.
结局指标
主要结局
Mortality
时间窗: 30 days
Mortality during the first 30 days after the episode of decompensation (at home or at the hospital).
Hospital admission
时间窗: 30 days
Hospital admission during the following 30 days as a consequence of the episode of decompensation. (We will consider hospital admission a stay at hospital \> 24 hours.)
次要结局
未报告次要终点