EUCTR2018-002699-42-DK进行中（未招募）1 期
Danish trial of beta blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK) - DANBLOCK
Bispebjerg Frederiksberg Hospital0 个研究点目标入组 2,760 人开始时间: 2018年7月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,760
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be eligible for this study the following inclusion criteria must be meet:
- •18 years or older
- •Left ventricular ejection fraction (LVEF) > 40%
- •Myocardial infarction (MI)
- •The diagnosis of acute MI must meet the Universal ESC definition of MI40:
- •Detection of a rise and/or fall of cardiac biomarker values with at least one value above the 99th percentile upper reference limit and with at least one of the followings:
- •Symptoms of ischaemia.
- •New or presumed new significant ST-segment–T wave (ST–T) changes or new left bundle branch block (LBBB).
- •Development of pathological Q waves in the ECG.
- •Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- •The inclusion- and event rate in DANBLOCK have been continuously assessed since the first patient was randomized in December 2018. The inclusion and event rate have been lower than expected, in part due to COVID-19. To enhance feasibility, the decision was made by the Steering Committees to
- •combine the data from DANBLOCK with the data from the Norwegian BETAMI (NCT03646357) and publish main results together.
- •The trials have similar designs, only minor differences in study entry criteria, and were, from the very beginning, coordinated with the aim of conducting substudies on pooled data. The primary endpoint has been harmonized without knowledge of the distribution of events. BETAMI and DANBLOCK will remain separate trials until the end of follow-up, where data from the trials will be combined and main results published together.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1380
排除标准
- •Exclusion Criteria
- •Patient will be excluded if they meet any of the following criteria:
- •Clinical evidence of heart failure at the time of discharge
- •Pregnancy or of child bearing age not using safe anticonception
- •Signed informed consent and expected cooperation during follow-up
- •Any medical condition where BB treatment is indicated according to the treating physician, which may include:
- •BB treated arrhythmias
- •BB treated hypertension
- •Cardiomyopathies
- •Seriously limited life-expectancy
- •Any condition (i.e. dementia) that could lead to increased risk for the patient when treated with BB-therapy
- •Any contraindication to BB treatment according to the treating physician, which may include:
- •Hypotension
- •Bradyarrhythmias
- •Severe peripheral artery disease
- •History of not able to tolerate BB-therapy
- •Severe COPD
- •Severe valvular heart disease
- •The exclusion is not limited to this list and the responsible treating physician will need consider if any other contraindication might exist for the patient. Both patients treated with a BB before their MI and patients in whom BB was initiated during the hospital admission are eligible for the trial.
研究者
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