Alternative in Beta Blocker Intolerance: The ABBI Trial

Minneapolis Heart Institute Foundation

Status and phase

Terminated

Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Nebivolol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00893984

pre001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

6 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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