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Alternative in Beta Blocker Intolerance: The ABBI Trial (ABBI)

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nebivolol
Sponsored by
Minneapolis Heart Institute Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Intolerance, Beta blocker

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Minneapolis Heart Institute at Abbott Northwestern Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nebivolol

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Termination of Bystolic Stratified by Reason
Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker
Number of Participants With Mild Symptoms
Mild symptoms include weight gain, edema, and headaches

Full Information

First Posted
May 5, 2009
Last Updated
July 29, 2019
Sponsor
Minneapolis Heart Institute Foundation
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00893984
Brief Title
Alternative in Beta Blocker Intolerance: The ABBI Trial
Acronym
ABBI
Official Title
Alternative in Beta Blocker Intolerance; the ABBI Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of patient recruitment
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minneapolis Heart Institute Foundation
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Intolerance, Beta blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nebivolol
Arm Type
Experimental
Arm Description
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Intervention Type
Drug
Intervention Name(s)
Nebivolol
Other Intervention Name(s)
Bystolic
Intervention Description
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Primary Outcome Measure Information:
Title
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
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Number of Participants With Termination of Bystolic Stratified by Reason
Time Frame
30 Days
Title
Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker
Time Frame
30 Days
Title
Number of Participants With Mild Symptoms
Description
Mild symptoms include weight gain, edema, and headaches
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham
Organizational Affiliation
Minneapolis Heart Institute Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis Heart Institute at Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18402537
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.
Results Reference
background
PubMed Identifier
16373195
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.
Results Reference
background
PubMed Identifier
16923412
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.
Results Reference
background
Links:
URL
http://www.mplsheart.com/
Description
Minneapolis Heart Institute
URL
http://www.mplsheart.org/
Description
Minneapolis Heart Institute Foundation

Learn more about this trial

Alternative in Beta Blocker Intolerance: The ABBI Trial

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