Beta-blockeRs tO patieNts With CHronIc Obstructive puLmonary diseasE
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,713
- 试验地点
- 2
- 主要终点
- Mortality, exacerbations and cardiovascular events
研究概览
简要总结
Background: In patients with chronic obstructive pulmonary disease (COPD) and concomitant cardiovascular conditions cardio-selective beta-blockers reduce mortality and can be used without significant negative effects on lung function or respiratory symptoms. Observational studies indicate that beta-blocker therapy in COPD even without overt cardiovascular disease, is associated with reduced risk for mortality and COPD exacerbations.
Aim: The overall purpose of our study is to examine the benefit of general beta-blocker therapy on important patient-oriented measures in chronic obstructive pulmonary disease (COPD). Our primary hypothesis that treatment with beta-blockers in patients with COPD and no comorbid heart disease at baseline can prevent a Composite measure of hospitalizations due to cardiovascular diseases, COPD exacerbations and death.
Population: 1700 patients with C OPD. Inclusion criteria are FEV1/FVC < 70, age >40 years and sinus rhythm 50-120/min. Exclusion criteria include hypersensitivity against metoprolol, atrioventricular (AV) block II or II or sick sinus syndrome without pacemaker, atrial fibrillation or flutter, clinical signs of or previously known cardiovascular disease, systolic blood pressure < 90, severe asthma, present beta-blocker therapy or ongoing COPD exacerbation.
Intervention: Metoprolol at a target dose of 100 mg in addition to standard COPD care.
Control: No placebo control. Randomized, pragmatic un-blinded controlled study where the control Group receives standard COPD care.
Outcome: The primary outcome is a composite measure of all-cause mortality, C OPD exacerbations, and cardiovascular events after one year. Endpoint data from Swedish national registries and clinical follow-up.
Importance: Beta-blocker treatment to attenuate morbidity in patients with COPD could have great clinical and social importance at a low cost.
详细描述
Purpose and aims
The overall purpose of our study is to examine the benefit of general beta-blocker therapy on important patient-oriented measures in chronic obstructive pulmonary disease (COPD). Our primary aim is to examine if treatment with beta-blockers in patients with COPD and no comorbid heart disease at baseline can prevent hospitalizations due to cardiovascular diseases, COPD exacerbations and death.
Background
In patients with chronic obstructive pulmonary disease (COPD) and concomitant cardiovascular conditions cardio-selective beta-blockers reduce mortality and can be used without significant negative effects on lung function or respiratory symptoms. Observational studies indicate that beta-blocker therapy in COPD even without overt cardiovascular disease, is associated with reduced risk for mortality and COPD exacerbations.
Research questions
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of COPD confirmed by spirometry showing post bronchodilator value of Forced Expiratory Volume in one second (FEV1)//Forced Vital Capacity (FVC) < 70 according to the Global Initiative on Obstructive Pulmonary Disease (GOLD)
- •≥40 years of age
- •Sinus rhythm ≥50/min and <120 at inclusion
排除标准
- •Known hypersensitivity to metoprolol or related derivatives
- •AV block II or III unless treated with a pacemaker
- •Sinus bradycardia (resting heart rate <50/min)
- •Sick sinus syndrome unless treated with a pacemaker
- •Atrial fibrillation/flutter
- •Clinical signs of or a previous diagnosis of heart failure, angina pectoris, myocardial infarction, cerebrovascular disease or critical peripheral ischemia
- •Systolic blood pressure <90 mmHg
- •Any tachy-arrythmias other than sinus rhythm
- •Sinus tachycardia >120 / min
- •Systolic blood pressure <90 mmHg
- •Severe bronchial asthma
- •Current beta-blocker treatment
- •Inability to provide informed consent
- •Age below 40 years
- •Acute on-going exacerbation of COPD
- •Previous randomization in the BRONCHIOLE trial
- •Ongoing pregnancy (excluded by pregnancy test in fertile women)
研究组 & 干预措施
Standard care
Usual standard care
干预措施: Standard care (Drug)
Metoprolol
Metoprolol at an aimed dose of 100 mg in addition to usual standard care
干预措施: Metoprolol (Drug)
结局指标
主要结局
Mortality, exacerbations and cardiovascular events
时间窗: One year
A composite measure of all-cause mortality, COPD exacerbations and cardiovascular events after one year
次要结局
- Mortality(One year)
- Exacerbations(One year)
- Cardiovascular events(One year)
研究者
Ole Frobert, MD, PhD
Professor
Region Örebro County