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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Alternative in Beta Blocker Intolerance; the ABBI Trial|
- Incidence of intolerance of Bystolic, measured by side effect(s) that lead to discontinuance of Bystolic by the patient and/or the physician [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Reason for termination of Bystolic [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Incidence of same symptom stopping Bystolic as previous beta blocker [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Symptom severity [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Other Name: Bystolic
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.
|United States, Minnesota|
|Minneapolis Heart Institute at Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|Principal Investigator:||Kevin J Graham, MD||Minneapolis Heart Institute Foundation|