Monitoring of Arrhythmias in Patients Treated With Antipsychotics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Monitoring of Arrhythmias in Patients Treated With Antipsychotics - The MAPP II Study

Conditions
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Death, Sudden, Cardiac, Arrythmia, Antipsychotics and Neuroleptics Toxicity

Intervention / Treatment
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* Drug: Antipsychotic


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antipsychotics<br>Patients treated with antipsychotics as provided by their psychiatrist in order to treat disease best possible and in accordance with guidelines. | Drug: Antipsychotic<br>* Antipsychotic treatment >0.5 DDD<br>|
| No Intervention: Control<br>Healthy controls, not treated with antipsychotics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular arrhythmias | Number of patients with ventricular arrhythmias detected on insertable loop recorder | 2 years from insertion og loop recorder | 

Secondary Outcome Measures

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