NCT00543881已完成3 期
Telemedical Interventional Monitoring in Heart Failure (TIM-HF)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 710
- 试验地点
- 4
- 主要终点
- all cause mortality
研究概览
简要总结
Superiority of additional Remote Patient Monitoring in patients with CHF In comparison to usual care in terms of:
- reduction of mortality rate
- reduction of hospitalizations
- increasement of patients' quality of life
详细描述
The clinical trial assesses 710 patients over a period of at least 15 months each (2008 until 2010); all participants will continue to receive usual care from their GP. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 355 of the patients will be randomly allocated to receive devices for Remote Patient Monitoring 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
- •Ambulatory CHF NYHA II or III
- •LVEF ≤ 35% and cardiac decompensation with hospitalization for heart failure or therapy with intravenous diuretics (.40 mg furosemide/day) within 24 months prior to enrolment or LVEF ≤ 25%, measured twice within past 6 months
- •Optimal medical treatment for CHF (b-blocker, ACE-inhibitor/ ARB, diuretics) including ICD/CRT if indicated
- •Age ≥ 18 years
- •Informed consent
排除标准
- •Existence of any disease (HF excluded) reducing life expectancy to less than 1 year
- •Insufficient compliance to telemonitoring or study visits
- •Impairment to use the telemonitoring equipment or appear to study visits (e.g. dementia, impaired self-determination, lacking ability to communicate)
- •Concurrent participation in other therapy trials
- •Hospitalization for cardiac decompensation within 7 days before inclusion in trial
- •Implanted cardiac assist system
- •Unstable angina pectoris
- •Congenital heart defect
- •Primary heart valve disease
- •Hypertrophic or restrictive cardiomyopathy
- •Arrhythmogenic right ventricular cardiomyopathy
- •Acute myocarditis diagnosis ,1 year
- •Actively listed for heart transplantation
- •Planned revascularization or CRT implantation
- •Chronic renal insufficiency with creatinine .2.5 mg/dl
- •Liver cirrhosis
- •Known alcohol or drug abuse
结局指标
主要结局
all cause mortality
次要结局
- comp of the combined rate of cv death and hosp. for worsening HF;days lost due to cv death or HF hosp;cv mortality;Rate of cv hosp;Rate of hosp for HF;hosp for any reason;cv hosp;hosp for HF;duration of all hosp for HF;NYHA class; SF-36; PHQ-9 score
研究者
Friedrich Koehler
Senior Physician
Charite University, Berlin, Germany
研究点 (4)
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