Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 507
- 试验地点
- 1
- 主要终点
- Number of participants with all cause death or unplanned hospitalization at 6 months
研究概览
简要总结
After decompensated heart failure, a number of patients have high risk of early rehospitalization as well as death. Specialized medical management for a short period but very early after discharge could be critical for optimizing care and improving early outcome.
This study aims to compare such early intensive medical management with usual care in high-risk patients after discharge.
详细描述
At discharge, high-risk HF patients are selected and randomized in two groups:
- Control group: usual disease management according to guidelines and including first medical consultation and biological test within the 4-week time following discharge.
- Active group: consultations with HF specialist including biological test at weeks 1, 2 and 4 are planned in addition to usual management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •18 years or more
- •consent signed
- •Acute or decompensated heart failure with one or more of following criteria::
- •Discharge BNP > 350 pg/ml or NTproBNP > 2200 pg/ml
- •Discharge serum creatinine ≥ 180µM
- •Discharge systolic blood pressure ≤ 110mmHg
- •Previous hospitalisation for acute heart failure < 6 months
排除标准
- •acute coronary syndrome,
- •acute myocarditis,
- •isolated right HF,
- •transient HF,
- •planned cardiac surgery,
- •high risk of short-term non-cardiac death,
- •planned management within rehabilitation center/HF clinic at discharge
研究组 & 干预措施
intensive disease management
Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
干预措施: Natriuretic peptides levels to J7 and J14 (Other)
intensive disease management
Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
干预措施: Consultations specialized to J7 and J14 (Other)
intensive disease management
Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
干预措施: Phone calls in 6 months and 12 months (Other)
intensive disease management
Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
干预措施: Natriuretic peptides levels at 6 months (Other)
intensive disease management
Planned consultations with HF specialist including biological test at weeks 1, 2 and 4; in addition to usual care.
干预措施: Consultation with the general doctor or the cardiologist to J30 with blood results (Other)
usual disease management
usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.
干预措施: Natriuretic peptides levels at 6 months (Other)
usual disease management
usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.
干预措施: Consultation with the general doctor or the cardiologist to J30 with blood results (Other)
usual disease management
usual care according to guidelines; including first medical consultation and biological test within the 4-week time following discharge.
干预措施: Phone calls in 6 months and 12 months (Other)
结局指标
主要结局
Number of participants with all cause death or unplanned hospitalization at 6 months
时间窗: 6 months
次要结局
- Number of alive and hospitalization-free days at 6 and 12 months(6 and 12 months)
- All cause mortality at 12 months(one year)
- Natriuretic peptides blood levels at 6 months.(6 months.)
- Global cost of patient management(from day0 to 12 months)
- Analysis of subgroups (LVEF altered or not, first HF episode or not, age> or ≤ 75, Changes in levels of BNP or NT-proBNP between day0 and the second consultation in the active group: ≥ 30% decrease, ≥ 30% increase, Intermediate variation).(6 months)
- Mean and distribution modified Goldman classe at 6 months(6 months)
- Unplanned HF-related hospitalization at 6 and 12 months(6 and 12 months)
- Biomarkers measured in plasma collected at day0: predictive value of the risk of death and hospitalization during the period of 6 months(6 months)
- HF-treatment at 6 months(6 months)
- Mean and distribution NYHA classe at 6 months(6 months)