Alternative in Beta Blocker Intolerance: The ABBI Trial
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/30/2013 |
| Start Date: | May 2009 |
| End Date: | June 2012 |
| Contact: | Sara D Olson, RN |
| Email: | sara.olson@allina.com |
| Phone: | 612-863-7601 |
Alternative in Beta Blocker Intolerance; the ABBI Trial
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.
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.
Inclusion Criteria:
- Age ≥ 21
- 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
Exclusion Criteria:
- 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
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