Alternative in Beta Blocker Intolerance: The ABBI Trial

Phase 4

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Drug: Nebivolol

• Registration Number: NCT00893984
• Lead Sponsor: Minneapolis Heart Institute Foundation

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-05-05
• Study First Posted: 2009-05-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2019-06-26
• Results First Submitted QC: 2019-06-26
• Status Verified: 2019-07
• Results First Posted: 2019-07-17
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nebivolol	Nebivolol	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 Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants With Termination of Bystolic Stratified by Reason	30 Days
Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker	30 Days
Number of Participants With Mild Symptoms	30 Days	Mild symptoms include weight gain, edema, and headaches

Trial Locations

Locations (1)

Minneapolis Heart Institute at Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States