Monitoring of Arrhythmias in Patients Treated With Antipsychotics

Not Applicable

Recruiting

• Conditions: Death, Sudden, Cardiac; Arrythmia; Antipsychotics and Neuroleptics Toxicity
• Interventions: Drug: Antipsychotic

• Registration Number: NCT04575103
• Lead Sponsor: Herlev and Gentofte Hospital

Brief 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.

Detailed Description

Aims and objectives To estimate frequency of potential malign arrhythmias and cardiovascular outcome in a population with patients treated with antipsychotic drugs compared to healthy controls.

Background Life expectancy is about 20 years shorter for patients with mental illness compared to the general population. Increasing evidence suggest that antipsychotic drugs can cause cardiac arrhythmias and hence sudden death. However, the evidence as well as the incidence of rhythm disturbances in patients treated with antipsychotic drugs is insufficient reported. Prolonged monitoring with external portable monitors is difficult for practical and technical reasons. In addition, long-term consistent and structured timing of clinical visits is often a challenge in this vulnerable patient group. In recent years, patients who have been suspected of rarely occurring arrhythmias, have been offered long-term monitoring using an 'implantable loop recorder' (ILR). However, no study has evaluated the arrhythmic burden in patients treated with antipsychotic drugs using ILR.

Methods and materials The study is a national joint project between departments of psychiatry and cardiology across Denmark. After written informed consent and a baseline evaluation including echocardiography, ecg and biochemistry, an ILR will be implanted. During follow-up, arrhythmias will be monitored at regular clinical visits. Cardiovascular endpoints will be monitored using Danish national registries.

Expected outcome and perspectives The present study is the first to reveal arrhythmias among patients treated with antipsychotics using consistent long-term monitoring. The results will give valuable insights into possible mechanism of the observed early death and risk of sudden death in patients treated with antipsychotics.

Study Timeline

• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Study Start: 2021-01-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antipsychotics	Antipsychotic	Patients treated with antipsychotics as provided by their psychiatrist in order to treat disease best possible and in accordance with guidelines.

Primary Outcome Measures

Name	Time	Method
Ventricular arrhythmias	2 years from insertion og loop recorder	Number of patients with ventricular arrhythmias detected on insertable loop recorder

Secondary Outcome Measures

Name	Time	Method
Supraventricular arrhythmias	2 years from insertion og loop recorder	Number of patients with supraventricular arrhythmias including atrial fibrillation or flutter detected on insertable loop recorder.
Bradycardia	2 years from insertion og loop recorder	Number of patients with bradycardia (defined as resting rate lower than 40/min) detected on insertable loop recorder.

Trial Locations

Locations (18)

Department of Psychiatry, Region of Southern Denmark; 🇩🇰 Aabenraa, Denmark

Aarhus Universitetshospital, Skejby, Department of Cardiology; 🇩🇰 Aarhus, Denmark

Bispebjerg Hospital, Department of Cardiology; 🇩🇰 Copenhagen, Denmark

Copenhagen Center of Psychiatry (Rigshospitalet); 🇩🇰 Copenhagen, Denmark

Mental Health Center Amager; 🇩🇰 Copenhagen, Denmark

Rigshospitalet, Department of Cardiology; 🇩🇰 Copenhagen, Denmark

Mental Health Center Frederiksberg; 🇩🇰 Frederiksberg, Denmark

Gentofte-Herlev Hospital, Department of Cardiology; 🇩🇰 Gentofte, Denmark

Mental Health Center Glostrup; 🇩🇰 Glostrup, Denmark

Mental Health Center Copenhagen; 🇩🇰 Hellerup, Denmark

North Zealand Hospital, Department of Psychiatry; 🇩🇰 Hillerød, Denmark

Zealand University Hospital, Department of Cardiology; 🇩🇰 Roskilde, Denmark

Odense University Hospital, Department of Cardiology; 🇩🇰 Odense, Denmark

Psychiatric Research Unit, Region of Zealand; 🇩🇰 Slagelse, Denmark

Cardiology, Aalborg Universitetshospital; 🇩🇰 Aalborg, Denmark

Psychiatry, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Psychiatry, Aarhus University; 🇩🇰 Aarhus, Denmark

North Zealand Hospital, Department of Cardiology; 🇩🇰 Hillerød, Denmark