Treating Clozapine-induced Sinustachycardia With Bisoprolol

University of Aarhus21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Clozapine-induced Sinustachycardia

Interventions

BisoprololDRUG

Bisoprolol "Vitabalnas" 10 mg once daily

PlaceboDRUG

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Aalborg University Hospital, Psychiatry

Aalborg, Denmark