Coronary Artery Disease
Conditions
Keywords
Intolerance, Beta blocker
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.
Interventions
DRUGNebivolol
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Sponsors
Forest Laboratories
Minneapolis Heart Institute Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nebivolol Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Nebivolol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nebivolol | 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 | 0 Participants |
Secondary
Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nebivolol | Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker | 0 Participants |
Secondary
Number of Participants With Mild Symptoms
Mild symptoms include weight gain, edema, and headaches
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nebivolol | Number of Participants With Mild Symptoms | 1 participants |
Secondary
Number of Participants With Termination of Bystolic Stratified by Reason
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nebivolol | Number of Participants With Termination of Bystolic Stratified by Reason | 0 Participants |