Telemedical Interventional Management in Heart Failure II
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,571
- 试验地点
- 124
- 主要终点
- Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time.
研究概览
简要总结
Superiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.:
- days lost due to unplanned cardiovascular hospitalization or death
- all-cause mortality
- cardiovascular mortality
- quality of life
详细描述
The clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). All participants will continue to receive usual care from their general practitioner and specialist. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 750 of the patients will be randomly allocated to receive devices for Remote Patient Management (RPM) which will measure various parameters on a daily basis (e.g. weight, blood pressure, heart rate). The devices are mobile and can be used at home or elsewhere.
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
- •chronic heart failure New York Heart Association (NYHA) class II or III
- •echocardiographically determined left ventricular ejection fraction (LVEF) ≤45% or >45% + minimum 1 diuretic in permanent medicinal therapy
- •hospitalization due to decompensated HF within the last 12months before randomization
- •informed consent
- •Depression score PHQ-9: <10
排除标准
- •hospitalization within the last 7 days before randomization
- •implanted cardiac assist system
- •acute coronary syndrome within the last 7 days before randomization
- •high urgent listed for heart transplantation (HTx)
- •planned revascularization, Transcatheter Aortic Valve Implantation (TAVI), MitraClip and/or Cardiac Resynchronization Therapy (CRT)-implantation within the last 3 months before randomization
- •revascularization and/or CRT-implantation within 28 days before randomization
- •known alcohol or drug abuse
- •terminal renal insufficiency with hemodialysis
- •impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate)
- •existence of any disease reducing life expectancy to less than 1 year
- •age <18 years
- •pregnancy
- •participation in other treatment studies or remote patient management programmes (register studies possible)
研究组 & 干预措施
Usual Care
control group
干预措施: Usual Care (Other)
Remote Patient Management
intervention group
干预措施: Remote Patient Management (Device)
结局指标
主要结局
Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time.
时间窗: 12 months/ individual-patient follow-up time.
The primary outcome analysis will be performed on the FAS using the adjudicated data and sensitivity analyses will be performed on a) the PP data set, and b) on the FAS censoring all data at day 365.
次要结局
- Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time(12 months/ individual follow-up time)
- Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.(12 months/ individual follow-up time)
- Change in MLHFQ-questionnaire overall score between baseline and 365 days(12 months/ individual follow-up time)
- Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days.(12 months/ individual follow-up time)
- All-cause mortality during the individual patient follow-up time.(individual patient follow-up time (+28 days of the final visit to a maximum 393 days))
研究者
Friedrich Koehler
Prof. Dr. Friedrich Koehler, MD, Senior Physician
Charite University, Berlin, Germany