Alternative in Beta Blocker Intolerance: The ABBI Trial

Stopped early · Phase 4

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00893984

Run by

Minneapolis Heart Institute Foundation

People needed

6

Starts

2009-05-01

Expected to finish

2012-06-01

Last updated by the study team

2019-08-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Minneapolis Heart Institute at Abbott Northwestern Hospital — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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