Atrial fibrillation Coronary artery bypass grafting
Conditions
Interventions
None listed
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Indication for metoprolol tartrate 25mg twice a day, being male or female, aged >= 60 years,
Exclusion criteria
Exclusion criteria: Contraindication or intolerance for metoprolol, diseases or patient characteristics which influences or reduces the absorption for metoprolol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the area under the time-concentration curve (AUC) of metoprolol on day three after CABG with heart valve surgery and any day after STEMI/NSTEMI in female versus male patients (called the day of the PK evaluation). Other primary endpoints are pharmacokinetic parameters including clearance (CL), volume of distribution (Vd), biological availability (F), absorption rate (Ka), maximum concentration (Cmax) and time to maximum plasma concentration (Tmax). For patients after CABG with heart valve surgery, postoperative day three is selected because on day 1 and 2 after surgery, absorption may be hampered. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study endpoints are the effects of metoprolol, i.e. absolute and delta heart rate, heart rhythm and blood pressure, and the occurrence of side effects such as hypotension, bradycardia, fatigue, dyspnea d*effort, cold hands and feet, Raynaud syndrome, dizziness, headache, nausea, vomiting, diarrhea and obstipation in female versus male patients on the day of PK evaluation, at discharge and at the first and second postoperative outpatient clinic visit. Other secondary endpoints are the need and reason for dose adjustments compared to the starting dose or need for discontinuation of treatment at these time points. Besides sex, the influence of other patient characteristics like age, indication and CYP2D6 genotype on the PK, effects and side effects are explored. | — |
Countries
Netherlands
Outcome results
None listed