Alternative in Beta Blocker Intolerance: The ABBI Trial

Condition(s) targeted: Coronary Artery Disease

Intervention: Nebivolol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Minneapolis Heart Institute Foundation

Official(s) and/or principal investigator(s):
Kevin J Graham, MD, Principal Investigator, Affiliation: Minneapolis Heart Institute Foundation

Overall contact:
Sara D Olson, RN, Phone: 612-863-7601, Email: sara.olson@allina.com

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.

Official title: Alternative in Beta Blocker Intolerance; the ABBI Trial

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of intolerance of Bystolic, measured by side effect(s) that lead to discontinuance of Bystolic by the patient and/or the physician

Secondary outcome:

Reason for termination of Bystolic

Incidence of same symptom stopping Bystolic as previous beta blocker

Symptom severity

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.

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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

Sara D Olson, RN, Phone: 612-863-7601, Email: sara.olson@allina.com

Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota 55407, United States; Recruiting
Sara D Olson, RN, Phone: 612-863-7601, Email: sara.olson@allina.com
Peg A Demmer, RN, CCRC, Phone: 612-863-6066, Email: peg.a.demmer@allina.com
Kevin J Graham, MD, Principal Investigator

Minneapolis Heart Institute

Minneapolis Heart Institute Foundation

Related publications:

Wojciechowski D, Papademetriou V. Beta-blockers in the management of hypertension: focus on nebivolol. Expert Rev Cardiovasc Ther. 2008 Apr;6(4):471-9. Review.

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.

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.

Starting date: May 2009
Last updated: June 28, 2011