NCT04575103

Monitoring of Arrhythmias in Patients Treated With Antipsychotics

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Antipsychotic	Antipsychotic treatment \>0.5 DDD

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2020-10-05
• Last updated: 2021-02-21

Locations

18 sites across 1 country: Denmark