Beta blockers vs Calcium channel blockers for rate control in Atrial Fibrillation with fast ventricular rate:A randomised open labelled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the effects of Metoprolol versus Diltiazem in decreasing heart rate to less than 110 beats per minute or 20% reduction of initial heart rate within 30 minutes of drug intake
研究概览
简要总结
This is a prospective, open labelled, randomised control trial of parallel group to compare the effects of intravenous Metoprolol versus Diltiazem in controlling heart rate in hemodynamically stable patients presenting to Emergency department with ECG features suggestive of Atrial Fibrillatiion with fast ventricular rate.Patients more than or equal to 18 years with an ECG evidence of fibrillation with heart rate more than 110 are included in the study after excluding patients meeting excluding criteria.Then patient will be randomised in two different arm based on block randomisation using computer generated sequences and allocation concealment will be done. Primary objective is to compare the effects of Metoprolol v/s Diltiazem in decreasing heart rate to less than 110 bpm or 20% reduction of initial heart rate within 30 minutes of drug administration, secondary objectives would be to evaluate the incidence of hypotension, bradycardia and requirement of second dose of same medication or subsequent doses of other class of medications for rate control and length of hospital stay in such patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All hemodynamically stable patients presenting to ED with ECG showing Atrial fibrillation with fast ventricular rate more than 110 beats per minute,consenting for study.
排除标准
- •1.pregnancy 2.systolic blood pressure less than 90mm of mercury 3.heart rate more than 220 beats per minute 4.QRS duration more than 120 milliseconds 5.Febrile patients with temperature more than 38 celsius 6.ECG suggestive of acute ST elevation Myocardial infarction 7.History of allergy to Diltiazem or Metoprolol 8.Acute decompensated heart failure patients with ejection fraction less than 40% or NYHA class 3,4 or patients with active wheezing or history of Bronchial asthma and Chronic obstructive pulmonary disease.
结局指标
主要结局
To compare the effects of Metoprolol versus Diltiazem in decreasing heart rate to less than 110 beats per minute or 20% reduction of initial heart rate within 30 minutes of drug intake
时间窗: The outcome of drug intake are estimated after 30 minutes.
次要结局
- To evaluate the incidence of hypotension(systolic blood pressure to less than 90 mm of mercury) and bradycardia (heart rate less than 60 beats per minute)(within 30 minutes of drug administration)
- To evaluate the incidence of requirement of second dose of same medication or subsequent doses of other class medication for rate control(Within 30 minutes of drug administration)
- To evaluate the incidence of length of ED stay(Within 30 minutes of drug administration)
研究者
Dr Anil Akhil
AIIMS New Delhi