Alternative in Beta Blocker Intolerance; the ABBI Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants With Intolerance of Bystolic, Measured by Side Effect(s) That Lead to Discontinuance of Bystolic by the Patient and/or the Physician
研究概览
简要总结
In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in cardiovascular patients who are not able to tolerate conventional beta blockers. A side effect profile will be tracked and compared with previous beta blocker use.
The investigators hypothesize that Bystolic will be tolerated by many patients who are intolerant of conventional blockers.
详细描述
Patients who have been prescribed standard beta blockers but were unable to tolerate them due to side effects will be studied. They will take a new beta blocker, Nebivolol (Bystolic) for 30 days, if tolerated. Side effects will be tracked and compared to previous.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female who is post-menopausal or not pregnant and using an approved contraceptive regimen
- •Previous beta blocker use and intolerant of beta blocker
排除标准
- •Systolic blood pressure < 100 mmHg unless another blood pressure medication is stopped at the time of study entry
- •Hospitalized for heart failure within the past 4 weeks
- •Bradycardia with a heart rate < 60
- •Heart block greater than first degree
- •History of sick sinus syndrome (unless a permanent pacemaker is in place)
- •History of severe hepatic or renal dysfunction; serum Creatinine > 2.0 or Amylase > 3x normal
- •Use of CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
- •Ingestion of investigational drug within the past 30 days
研究组 & 干预措施
Nebivolol
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
干预措施: Nebivolol (Drug)
结局指标
主要结局
Number of Participants With Intolerance of Bystolic, Measured by Side Effect(s) That Lead to Discontinuance of Bystolic by the Patient and/or the Physician
时间窗: 30 Days
次要结局
- Number of Participants With Termination of Bystolic Stratified by Reason(30 Days)
- Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker(30 Days)
- Number of Participants With Mild Symptoms(30 Days)