Day-care Unit for Patients With Refractory Heart Failure - a Single-centre Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of participants with rehospitalization due to heart failure decompensation
研究概览
简要总结
The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is an observational study on selected patients with advanced refractory heart failure. The purpose of the study was to examine the comprehensive management of HF in the day-care unit in terms of the safety and its impact on the rehospitalization and mortality rates in patients with advanced refractory HF.
详细描述
The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is a single-center observational study conducted in the 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Silesian Centre for Heart Disease in Zabrze, Poland.
The main objective of the DayCare-HF is to verify the hypothesis that comprehensive and multidisciplinary day-care management of patients with refractory heart failure (HF) is safe and beneficial in terms of hospital readmission due to HF and al cause mortality.
The study population is formed by selected patients with heart failure, hospitalized in cardiology wards and intensive cardiac care unit of Silesian Centre for Heart Disease, who fulfilled eligibility criteria.
During the scheduled visits comprehensive medical service is provided, including education, diagnostic tools (electrocardiography, transthoracic echocardiography, implanted cardioverter defibrillator (ICD) / cardiac resynchronization therapy device (CRT) interrogation and additional treatment (intravenous loop diuretic, dobutamine, vasodilators administration).
The patients are under constant follow-up for major adverse events, heart transplantation, hospital readmissions due to HF and all cause mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Optimally decongested heart failure in New York Heart Association (NYHA) class II-IV, treated for at least 6 months
- •Performance of all possible reparative procedures if indications were present (cardiac revascularization, correction of valvular heart disease, cardiac ablation, cardiac resynchronization therapy)
- •Implantation of cardioverter-defibrillator (ICD) if applicable
- •At least two unplanned hospitalizations for heart failure during preceding 6 months
排除标准
- •Inability to travel to the unit
- •Non-compliance with the medical recommendations
研究组 & 干预措施
DayCare-HF
Comprehensive service in day-care unit, including education, diagnostic tools (i.e. electrocardiography, transthoracic echocardiography, implanted cardioverter defibrillator (ICD) / cardiac resynchronization therapy device (CRT) interrogation and possibility of intravenous drug administration (i.e. loop diuretics, dobutamine).
干预措施: treatment in day-care heart failure unit (Other)
结局指标
主要结局
Number of participants with rehospitalization due to heart failure decompensation
时间窗: From date of inclusion until the date of death from any cause, assessed up to 1 year
次要结局
- Number of participants with major adverse cardiovascular event(From date of inclusion until the date of death from any cause, assessed up to 1 year)
- Number of participants with reported deaths from any cause(From date of inclusion until the date of death from any cause, assessed up to 1 year)
研究者
Mariusz Gasior
MD, PhD, Professor
Silesian Centre for Heart Diseases