Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction (DANBLOCK)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,760
- 试验地点
- 1
- 主要终点
- A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin.
研究概览
简要总结
To determine whether long-term treatment with oral betablocker therapy after myocardial infarction in patient with no heart failure reduces the composite outcome of recurrent MI, all-cause mortality, revascularisation with percutaneous coronary intervention or coronary artery bypass graft, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin.
详细描述
Aim: To determine whether long-term treatment with oral betablocker (BB) therapy after myocardial infarction (MI) in patient with no heart failure reduces the composite outcome of recurrent MI, all-cause mortality, revascularisation with percutaneous coronary intervention or coronary artery bypass graft, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin.
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 the primary endpoint, key secondary endpoints and most other secondary endpoints together (presented below).
The trials have similar designs, only minor differences in study entry criteria, and were, from the very beginning, coordinated with the aim of conducting sub-studies 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.
Intervention: BB therapy versus no therapy.
Main Inclusion Criteria: Patient that have suffered a MI, both Non-ST elevation MI and ST elevation MI and can be randomized within 14 days of MI with no signs of heart failure and a left ventricular ejection fraction>40%.
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
- •Left ventricular ejection fraction > 40%
- •Myocardial infarction (MI) within previous two weeks
- •The diagnosis of acute MI must meet the Universal European Society of Cardiology (ESC) definition of MI
排除标准
- •Clinical evidence of heart failure at the time of discharge
- •Pregnancy or of child bearing age not using safe anticonception throughout the study period
- •Lack of signed informed consent and expected cooperation during follow-up
- •Any medical condition where beta blocker treatment is indicated according to the treating physician
研究组 & 干预措施
Beta blocker treatment
Treatment with beta blockers plus standard of care. Type and dosage according to treating cardiologist choice
- Bisoprolol up to a total dose of 10 mg daily
- Carvedilol up to a total dose of 50 mg daily
- Metoprolol succinate up to a total dose of 200 mg daily
- Nebivolol up to a total dose of 10 mg daily
干预措施: Metoprolol Succinate (Drug)
Beta blocker treatment
Treatment with beta blockers plus standard of care. Type and dosage according to treating cardiologist choice
- Bisoprolol up to a total dose of 10 mg daily
- Carvedilol up to a total dose of 50 mg daily
- Metoprolol succinate up to a total dose of 200 mg daily
- Nebivolol up to a total dose of 10 mg daily
干预措施: Bisoprolol (Drug)
Beta blocker treatment
Treatment with beta blockers plus standard of care. Type and dosage according to treating cardiologist choice
- Bisoprolol up to a total dose of 10 mg daily
- Carvedilol up to a total dose of 50 mg daily
- Metoprolol succinate up to a total dose of 200 mg daily
- Nebivolol up to a total dose of 10 mg daily
干预措施: Carvedilol (Drug)
Beta blocker treatment
Treatment with beta blockers plus standard of care. Type and dosage according to treating cardiologist choice
- Bisoprolol up to a total dose of 10 mg daily
- Carvedilol up to a total dose of 50 mg daily
- Metoprolol succinate up to a total dose of 200 mg daily
- Nebivolol up to a total dose of 10 mg daily
干预措施: Nebivolol (Drug)
结局指标
主要结局
A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin.
时间窗: Estimated follow-up min 6 months - max 6.25 years
Time to the composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiag origin on an intention to treat analysis. The composite outcome will be assessed through nationwide registries and adjudicated by an independent Clinical Endpoint Adjudication Committee.
次要结局
- Recurrent myocardial infarction(Estimated follow-up min 6 months - max 6.25 years)
- All-cause mortality(Estimated follow-up min 6 months - max 6.25 years)
- Malignant ventricular arrhythmias(Estimated follow-up min 6 months - max 6.25 years)
- Incident heart failure (diagnosed at hospitalization or at out-patient visits)(Estimated follow-up min 6 months - max 6.25 years)
- Unplanned coronary revascularization(Estimated follow-up min 6 months - max 6.25 years)
- Ischemic stroke(Estimated follow-up min 6 months - max 6.25 years)
- Resuscitated cardiac arrest of cardiac origin(Estimated follow-up min 6 months - max 6.25 years)
- Cardiovascular mortality(Estimated follow-up min 6 months - max 6.25 years)
- Hospitalization for stable and unstable angina pectoris(Estimated follow-up min 6 months - max 6.25 years)
- Hospitalization for atrial fibrillation, atrial flutter or other tachyarrhythmias(Estimated follow-up min 6 months - max 6.25 years)
- Hospitalization for bradycardia, AV-block, syncope, or need for pacemaker(Estimated follow-up min 6 months - max 6.25 years)
- Hospitalization for asthma and chronic obstructive pulmonary disease symptoms(Estimated maximal follow-up 6 months - 6.25 years)
- Hospitalization or outpatient visit for peripheral artery disease(Estimated follow-up min 6 months - max 6.25 years)
- Hospitalization or outpatient visit for new-onset or dysregulated diabetes (DANBLOCK only)(Estimated follow-up min 6 months - max 6.25 years)
- Angina symptoms(E-questionnaires will be administered at inclusion, 3, 12 and 24 months)
- Exercise capacity (DANBLOCK only)(At the beginning of cardiac rehabilitation (within approximately 4 weeks after randomization) and at the end of cardiac rehabilitation (approximately 6-12 weeks after beginning of rehabilitation))
- Blood pressure control (DANBLOCK only)(At the beginning of cardiac rehabilitation (within approximately 4 weeks after randomization) and at the end of cardiac rehabilitation (approximately 6-12 weeks after beginning of rehabilitation))
- Quality of life measure(E-questionnaires will be administered at inclusion, 3, 12 and 24 months)
- Measures of depression and anxiety(E-questionnaires will be administered at inclusion, 3, 12 and 24 months)
- Measures of sexual dysfunction(E-questionnaires will be administered at inclusion, 3, 12 and 24 months)
- Measures of sleeping disorder(E-questionnaires will be administered at inclusion, 3, 12 and 24 months)
- Adherence to the prescribed dosage of beta-blocker(Estimated follow-up min 6 months - max 6.25 years)
- 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(Estimated follow-up min 6 months - max 6.25 years)
研究者
Eva Prescott
Professor, MD, PhD
Bispebjerg Hospital