Alternative in Beta Blocker Intolerance: The ABBI Trial

Coronary Artery Disease Clinical Trial

— ABBI  

Official title:

Alternative in Beta Blocker Intolerance; the ABBI Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00893984
• Other study ID #: pre001
• Status: Terminated
• Phase: Phase 4
• Start date: May 2009
• Est. completion date: June 2012

Study information

• Verified date: July 2019
• Source: Minneapolis Heart Institute Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Nebivolol
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.

Locations

Country	Name	City	State
United States	Minneapolis Heart Institute at Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation	Forest Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		30 Days
Secondary	Number of Participants With Termination of Bystolic Stratified by Reason		30 Days
Secondary	Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker		30 Days
Secondary	Number of Participants With Mild Symptoms	Mild symptoms include weight gain, edema, and headaches	30 Days

External Links

•   Minneapolis Heart Institute
•   Minneapolis Heart Institute Foundation