Monitoring of Arrhythmias in Patients Treated With Antipsychotics

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Antipsychotics may be associated to life-threatening arrhythmias and sudden cardiac death. This is the fist study to estimated the arrhythmic burden using long-term monitoring by implantable loop recorder in patients treated with antipsychotics.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Herlev and Gentofte Hospital
• Collaborators: Aalborg University Hospital; Aarhus University Hospital; Bispebjerg Hospital; Nordsjaellands Hospital; Odense University Hospital; Rigshospitalet, Denmark; University Hospital, Gentofte, Copenhagen; Zealand University Hospital
• Treatments: Antipsychotic Agents

Criteria

Inclusion Criteria:

• Patients with SMI defined according to ICD-10 as:

• F20.0-F20.9 schizophrenia

• F22.0-F22.9 paranoid psychosis

• F25.0-F25.9 schizo-affective psychosis

• F28 other non-organic psychosis

• F29 non-organic psychosis unspecified

• F31.0-F31.9 bipolar affective disorder.

• Patients treated with or initiating antipsychotics with ≥ 0.5 daily defined dosage

• >18 years old and <50 years.

Exclusion Criteria:

• Patients not capable to understand the aim of the study as judged by investigator.

• Current in treatment with methadone.

• Left ventricular hypertrophy (echocardiographic septal thickness ≥1.3 cm for women and ≥1.4 cm for men, or LVM/BSA ≥109 g/m2 for women or ≥132 g/m2 for men).

• Heart failure (echocardiographic LVEF <35%).

• Ischemic heart disease (patient reported coronary bypass grafting or percutaneous coronary intervention.

• Congenital cardiovascular disease (patient reported).