Alternative in Beta Blocker Intolerance: The ABBI Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alternative in Beta Blocker Intolerance; the ABBI Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Nebivolol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebivolol<br>Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control. | Drug: Nebivolol<br>* Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.<br>* Other names: Bystolic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Mild symptoms include weight gain, edema, and headaches | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intolerance, Beta blocker