NCT00542945已完成不适用
A DANish Randomized, Controlled, Multicenter Study to Assess the Efficacy of Implantable Cardioverter Defibrillator in Patients With Non-ischemic Systolic Heart Failure on Mortality. The DANISH Study
Danish Study Group2 个研究点 分布在 1 个国家目标入组 1,116 人开始时间: 2008年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,116
- 试验地点
- 2
- 主要终点
- All cause mortality
研究概览
简要总结
The primary objective of this study is to determine the efficacy of ICD therapy compared with control on the endpoint of death from any cause in patients with heart failure of non-ischemic oetiology.
详细描述
Title: A DANish randomized, controlled, multicenter study to assess the efficacy of Implantable cardioverter defibrillator in patients with non-ischemic Systolic Heart failure on mortality.
Indication: Prevention of mortality in patients at risk of sudden death.
Primary objective: The primary objective of this study is to determine the efficacy of ICD therapy compared with control on the endpoint of death from any cause.
Secondary objective: The secondary objectives of the study are to determine if ICD therapy reduces sudden death.
Study design: Randomized, unblinded, controlled, parallel two group trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 of age at the time of screening.
- •Documented non-ischemic HF with an LVEF ≤ 35%.
- •NYHA class II-III. If patients are planned for an implantation with a biventricular pacemaker NYHA class IV patients will be accepted for the trial.
- •Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained (see section 12.1).
- •NT-proBNP above 200 pg/ml (see appendix D).
排除标准
- •To be eligible for this study, subjects must not meet any of the following criteria:
- •Uncorrected congenital heart disease or valve obstruction, obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease.
- •On the urgent waiting list for a heart transplant (UNOS category 1A or 1B, or equivalent). Patients on the non-urgent waiting list for a heart transplant (UNOS category 2 or 7, or equivalent) are eligible for inclusion in the study.
- •Recipient of any major organ transplant (eg, lung, liver, heart or kidney).
- •Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 month before randomisation or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with a life expectancy of > 2.5 years in the opinion of the investigator).
- •Known to be human immunodeficiency virus positive with an expected survival of less than 5 years due to HIV.
- •Renal failure treated with dialysis.
- •Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report
- •Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- •Unwilling to participate.
研究组 & 干预措施
A
Experimental
Heart Failure nonischemic ethiology
干预措施: ICD (Device)
B
Active Comparator
干预措施: Optimal medical treatment (Other)
结局指标
主要结局
All cause mortality
时间窗: 5 years
次要结局
- Quality of Life and health economics(5 years)
研究者
研究点 (2)
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