BEta Blocker dEprescription Following Coronary Artery Bypass Graft sURGERy: Feasibility and Safety Pilot (BEEFBURGER Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of stroke
研究概览
简要总结
Beta-blockers have the greatest cardiovascular impact in patients with reduced heart function/heart failure and in reducing the peri-operative risk of atrial fibrillation. In patients without these high-risk features treated with coronary artery bypass graft (CABG) surgery, their continued long-term role is unclear.
详细描述
This is an open-label, non-inferiority, randomized comparison of beta-blocker continuation versus de-prescription at the 6-8 week follow-up following isolated and uncomplicated CABG at Royal University Hospital, Saskatoon.
Patients treated with isolated CABG (without valve repair/replacement) and discharged on a beta-blocker are eligible for recruitment if they have preserved systolic function (EF ≥45%) and no history of heart failure, atrial fibrillation/flutter, or an alternate compelling indication for beta-blocker therapy. After obtaining informed consent, eligible patients are randomly assigned at 6-8 weeks to one of the two treatment groups: continued beta-blocker therapy per their usual clinical care OR beta-blocker de-prescription as per the study protocol.
The primary objective of this study is to demonstrate recruitment feasibility for beta-blocker de-prescription 6-8 weeks following uncomplicated CABG. Exploratory outcomes include the composite of all-cause mortality, myocardial infarction, stroke, arrhythmia, and cardiovascular-related hospitalization (congestive heart failure, recurrent ischemia, arrhythmia [supraventricular including atrial fibrillation, and ventricular], syncope or need for pacemaker) over a 3-year follow up duration.
Other exploratory outcomes will include a change in the patient reported quality of life using the Short Form (SF) 36 and Euro Qol (EQ) 5D questionnaires and angina score using the Seattle Angina Questionnaire (SAQ).
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
- •Age ≥ 18 years treated with index isolated CABG
- •Able to consent to study
- •On beta blocker therapy at the 6-8week visit
- •LV systolic function (≥45% assessed within 6months of CABG date)
排除标准
- •Prior heart failure with reduced ejection fraction (LVEF <45%)
- •Pre- or peri-operative atrial fibrillation or flutter
- •Peri-CABG stroke
- •Unable to follow-up
研究组 & 干预措施
De-prescribe beta blocker therapy
Beta blocker therapy will be de-prescribed in this arm
干预措施: De-prescribe beta blocker therapy (Drug)
结局指标
主要结局
Rate of stroke
时间窗: 3 Years
On the basis of CT or MRI imaging or autopsy, stroke is classified as: * Ischemic stroke (including hemorrhagic transformation of ischemic stroke) * Hemorrhagic stroke (including intracerebral / intraparenchymal hemorrhage and subarachnoid hemorrhage) * Undetermined stroke (no imaging or autopsy available)
Rate of hospitalizations for heart failure
时间窗: 3 Years
Physician decision to treat heart failure with intravenous furosemide, if already on oral diuretics (for an alternate indication other than prior congestive heart failure (CHF\*), a 50% dose increase) with New York Heart Association class III or IV symptoms plus at least one of the following: * Presence of pulmonary edema or pulmonary vascular congestion on chest radiograph thought to be due to heart failure * Rales reaching above the lower 1/3 of the lung fields thought to be due to heart failure or * Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) \>18 mm Hg * Patients with a prior history of heart failure are not eligible for randomization.
Rate of cardiac arrhythmia
时间窗: 3 Years
Supraventricular (excluding atrial fibrillation) * Includes all forms of Supraventricular tachycardia (SVT) such as atrioventricular reentry tachycardia (AVRT), atrioventricular node reentry tachycardia (AVNRT), atrial tachycardia * Atrial fibrillation Any new finding of clinical atrial fibrillation lasting greater than 30 seconds plus at least one of the following: * ECG * Rhythm strip * If ECG document or Holter report is unavailable, clear physician diagnosis Ventricular Non-sustained or sustained ventricular tachycardia or ventricular fibrillation
Rate of syncope or need for permanent pacemaker
时间窗: 3 Years
Syncope suspicious for cardiac etiology requiring either hospitalization for ≥ 24 hours or needing an implantable monitoring device (such as loop recorder) or permanent pacemaker
Rate of all-cause mortality
时间窗: 3 years
All-cause death includes death resulting from both cardiovascular and non-cardiovascular causes.
Rate of spontaneous myocardial infarction
时间窗: 3 Years
All spontaneous (type 1) myocardial infarctions as per the Universal MI definition. Typical rise or fall of biochemical markers of myocardial necrosis to greater than twice the upper limit of normal (ULN). If markers were already elevated, and have not reached their peak then further elevation of a marker ≥50% of a previous value and \>2X ULN is required. If biomarkers are stable or decreasing then a re-elevation of ≥ 20% and \> 2X ULN is required. All also require meeting at least one of the following criteria: * Ischemic symptoms * Development of new pathological Q waves (distinct from index STEMI) * ECG changes of new ischemia or * Pathological evidence of MI
Rate of recurrent myocardial ischemia
时间窗: 3 Years
Hospitalization or stay in the emergency department for ≥ 24 hours for myocardial ischemia or requiring unplanned revascularization
次要结局
- Change in patient reported quality of life (QoL) using Euro Qol (EQ) 5D questionnaire(3 years)
- Change in patient reported quality of life using Short Form (SF) 36 questionnaire(3 years)
- Change in the patient reported angina score using the Seattle Angina Questionnaire (SAQ)(3 years)
研究者
Jay Shavadia
Assistant Professor Cardiology
University of Saskatchewan