Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- all cause mortality and hospitalization for worsening heart failure
研究概览
简要总结
The purpose of the study is to test a new medical device for optimizing treatment of heart failure and compare its effect on outcome of patients with a recent hospitalization for worsening heart failure
详细描述
Patients after an episode of acute heart failure have an increased risk of rehospitalisation and impaired prognosis for survival. Neither a sole mobile nurse support nor a sole telemonitoring system has been able to provide consistent data on a beneficial influence on prognosis. Furthermore, the influence of frequent measurements of NT-pro-BNP in a home setting of heart failure patients has not been investigated so far.
This study will test a new medical device (software) for optimizing treatment of heart failure patients and evaluate its impact on outcome of these patients.
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
- •acute systolic heart failure with admission for at least 4 consecutive days
- •treatment with an ACE-inhibitor/angiotensin receptor blocker, beta-blocker, mineralocorticoid receptor antagonist according to current ESC-guidelines
- •treatment with a loop diuretic
- •stable renal function (eGFR according to MDRD of at least 30ml)
- •written informed consent
- •minimum age of 18 years
排除标准
- •unstable coronary artery disease with revascularisation of any type within the last two months
- •planned revascularisation or operation for valvular heart disease within the next 6 months
- •planned heart transplantation
- •uncontrolled hypertension
- •active myocarditis
- •malignant disease with a life expectancy of less than 18 months
- •chronic use of high-dose NSAID or COX-2-inhibitors
- •psychiatric disorders that make it unlikely to understand the protocol
- •participation in an other randomized trial
- •inability to operate a smartphone
研究组 & 干预措施
telemonitoring
patients in the telemonitoring arm will record vital parameters (blood pressure, heart rate, body weight) and transmit these parameters together with wellbeing and daily dose of heart failure medication
干预措施: telemonitoring (Other)
control
patients in the control arm will not record any vital parameter
干预措施: control (Other)
结局指标
主要结局
all cause mortality and hospitalization for worsening heart failure
时间窗: 12 months
outcome assessment will be done by a blinded committee
次要结局
- days alive and out of hospital(12 months)