Treating Clozapine-induced Sinustachycardia With Bisoprolol

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Clozapine-induced sinustachycardia occurs in 25% of patients treated with clozapine and sustained sinustachycardia might be a risk factor for dilated cardiomyopathy. This double-blinded cross over placebo controlled study investigate whether 10 mg bisoprolol are efficient in treating clozapine-induced sinustachycardia measured as heart rate, heart rate variability, QTc and T-wave morphology.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Aalborg Universitetshospital; Aalborg University; Aalborg University Hospital
• Treatments: Bisoprolol; Clozapine

Criteria

Inclusion Criteria:

• Treated with clozapine > 3 months and minimum 100 mg/day

• Fixed dose 14 days before inclusion

• Heart rate > 100 (ECG)

• Pregnancy test negative

• Clozapine-induced sinustachycardia documented by ECG or case record

• Sexual abstinence or contraception

• Informed consent

Exclusion Criteria:

• Substance abuse

• Physical diseases, contraindications for clozapine or bisoprolol

• Asthma or chronic obstructive lung disease

• Blood pressure < 100/60 or recent history of syncopes

• QTc>500 ms, SA-block, AV- block II or III

• Restrictions by Danish mental act

• Allergic to clozapine or bisoprolol