Alternative in Beta Blocker Intolerance: The ABBI Trial

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Minneapolis Heart Institute Foundation
• Collaborator: Forest Laboratories
• Treatments: Adrenergic beta-Antagonists; Nebivolol

Criteria

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