2024-515748-22-01已完成3 期
Danish trial of beta blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK)
Frederiksberg Hospital18 个研究点 分布在 1 个国家目标入组 2,760 人开始时间: 2024年8月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,760
- 试验地点
- 18
- 主要终点
- The composite outcome of recurrent MI, all-cause mortality, revascularization with percutaneous coronary intervention or coronary atery bypass graft, ischemic stroke, incident heart faliure, malignant ventricular arrythmia or resuscitated cardiac arrest.
研究概览
简要总结
The composite outcome of recurrent MI, all-cause mortality, revascularization with percutaneous coronary intervention or coronary artery bypass graft, ischemic stroke, incident heart failure, malignant ventricular arrhythmia or resuscitated cardiac arrest.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The composite outcome of recurrent MI, all-cause mortality, revascularization with percutaneous coronary intervention or coronary atery bypass graft, ischemic stroke, incident heart faliure, malignant ventricular arrythmia or resuscitated cardiac arrest.
The composite outcome of recurrent MI, all-cause mortality, revascularization with percutaneous coronary intervention or coronary atery bypass graft, ischemic stroke, incident heart faliure, malignant ventricular arrythmia or resuscitated cardiac arrest.
次要结局
- To study whether oral beta-blocker therapy increases the risk of hospitalization for chronic obstructive pulmonary disease, asthma or peripheral artery disease.
- To study whether oral beta-blocker therapy increases the risk of hospitalization or outpatient visit for new-onset or dysregulated diabetes
- To study whether oral beta-blocker therapy affects the following patient related outcomes: Quality of life, angina, dyspnoea, anxiety, depression, sexual dysfunction or sleep disorders.
- To conduct cost-utility analysis in relation to quality of life and a health economic evaluation including drug use, health care utilization, employment, income, and benefit take-up
- To describe beta-blocker dosage and adherence
- To assess study safety
- Each of the components of the primary endpoint, i.e.: All-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, malignant ventricular arrhythmia, or resuscitated cardiac arrest.
- To assess clinical outcomes linked to beta-blocker therapy in the following subgroups: age, sex, BB dosage tertiles, STEMI vs. NSTEMI, and LVEF subgroups
- To study whether oral beta-blocker therapy reduces the risk of cardiovascular death compared to no such therapy
- To study whether oral beta-blocker therapy reduces the risk of stable and unstable angina compared to no such therapy
- To study whether oral beta-blocker therapy reduces the risk of atrial fibrillation, atrial flutter or other atrial tachyarrhythmias compared to no such therapy
- To study whether oral beta-blocker therapy increases the risk of hospitalization for bradycardia, syncope, implantation of pacemaker
研究者
Eva Prescott
Scientific
Frederiksberg Hospital
研究点 (18)
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