Clinical trial NCT00893984: Alternative in Beta Blocker Intolerance: The ABBI Trial
Official title: Alternative in Beta Blocker Intolerance; the ABBI Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Intolerance
Beta blocker
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2009-05-06
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Intolerance of Bystolic, Measured by Side Effect(s) That Lead to Discontinuance of Bystolic by the Patient and/or the Physician
timeFrame: 30 Days
Secondary outcomes:
measure: Number of Participants With Termination of Bystolic Stratified by Reason
timeFrame: 30 Days
measure: Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker
timeFrame: 30 Days
measure: Number of Participants With Mild Symptoms
timeFrame: 30 Days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute at Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Minneapolis Heart Institute Foundation
name: Graham
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wojciechowski D, Papademetriou V. Beta-blockers in the management of hypertension: focus on nebivolol. Expert Rev Cardiovasc Ther. 2008 Apr;6(4):471-9. doi: 10.1586/14779072.6.4.471.
citation: Weber MA. The role of the new beta-blockers in treating cardiovascular disease. Am J Hypertens. 2005 Dec;18(12 Pt 2):169S-176S. doi: 10.1016/j.amjhyper.2005.09.009.
citation: Kramer JM, Hammill B, Anstrom KJ, Fetterolf D, Snyder R, Charde JP, Hoffman BS, Allen LaPointe N, Peterson E. National evaluation of adherence to beta-blocker therapy for 1 year after acute myocardial infarction in patients with commercial health insurance. Am Heart J. 2006 Sep;152(3):454.e1-8. doi: 10.1016/j.ahj.2006.02.030.