Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- days alive out of hospital 6 months post discharge
研究概览
简要总结
Evaluate the benefit of systematic appointment with a cardiologist a week after hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of hospital during 6 months
详细描述
Background: the risk for rehospitalisation is very high after hospitalisation for acute heart failure. Aim: evaluate the benefit of a consultation with a cardiologist, including echocardiography and education of the patient, between 7 and 15 days after discharge, in high risk patients, identified with BNP or incomplete therapy. Parallel randomised study. The main endpoint is the number of day alive out of hospital during the 6 months post discharge; statistics intention to treat comparison of the number of days alive out of hospital in the group with consultation compared with the group without consultation. Recruitment 3 years and 4 months, follow-up 6 months. Patients included have been hospitalised in hospital BICHAT 75018 Paris, France. Financing is by the ministry of health (PHRQHOS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Criteria of inclusion :
- •Patient with decompensated heart failure hospitalized in the hospital BICHAT,
- •For whom is planned a return at home,
- •Valid (being able to return for a consultation to the hospital)
- •Having Nt-ProBNP of exit ≥ 3500 ng /l and/or a non optimized treatment of exit - according to the doctor who has it the responsibility,
- •Having signed the consent form by participation in the study.
- •Criteria of not inclusion :
- •Age < 18 years,
- •Not membership in a national insurance scheme or in the Universal Health
- •Coverage (CMU)(FREE UNIVERSAL HEALTH CARE)(A patient benefiting from the Medical aid of the State (AME) cannot be included)
- •Participation to another protocol of research,
- •Not being reachable by telephone in 6 months.
排除标准
- 未提供
研究组 & 干预措施
Control
usual care without systematic cardiology evaluation between 1 and 2 weeks
Follow-up
Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary
干预措施: Follow-up (Other)
结局指标
主要结局
days alive out of hospital 6 months post discharge
时间窗: 6 months
次要结局
- number of patients having an optimal treatment at 6 months(6 months)
- mortality at 3 and 6 months(3 and 6 months)
- rehospitalisation rate at 6 months(6 months)
- autoevaluation of improvement/alteration of the patient state at 6 months(6 months)
- number of patients receiving a ACEI at 6 months(6 months)
- QOL at 6 months(6 months)
- number of patients receiving beta-blocker at 6 months(6 months)
- number of patients receiving beta-blocker at 3 months(3 months)
- number of patients receiving a ACEI at 3 months(3 months)
- QOL at 3 months(3 months)
- autoevaluation of improvement/alteration of the patient state at 3 months(3 months)
- number of patients having an optimal treatment at 3 months(3 months)