Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04575103
Study type Interventional
Source Herlev and Gentofte Hospital
Contact Casper N Bang, MD, PhD
Phone +4538635000
Email casper.niels.furbo.bang@regionh.dk
Status Recruiting
Phase N/A
Start date January 1, 2021
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Completed NCT00376532 - Extracellular Matrix Marker of Arrhythmia Risk (EMMA) N/A
Recruiting NCT04848844 - The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)
Completed NCT06039397 - The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure N/A
Completed NCT04025762 - 24/7 Closed-loop in Older Subjects With Type 1 Diabetes N/A
Not yet recruiting NCT03619018 - All Inclusive KODEX - EPD™ Study Patient Specific Optimized Therapy (PSOT) Study
Completed NCT03786640 - Abbott Brady 3T MRI PMCF
Recruiting NCT05935007 - Aveir DR Real-World Evidence Post-Approval Study
Recruiting NCT05932602 - AVEIR DR Coverage With Evidence Development (CED) Study
Recruiting NCT01988064 - Face to Face vs. Group Training Methods on Pulse Rate Taking in Patients With Cardiovascular Diseases. N/A
Recruiting NCT06310707 - Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter N/A
Terminated NCT03481413 - Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study
Recruiting NCT05443321 - Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes N/A
Recruiting NCT03801681 - ARrhythmias in MYocarditis
Completed NCT03628534 - SERF VT Ablation Early Feasibility Study (EFS) N/A
Recruiting NCT05034432 - The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients Phase 4
Recruiting NCT04856267 - Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders
Not yet recruiting NCT06414447 - Electrocardiogram (ECG) Validation Study
Completed NCT02401659 - Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems N/A
Recruiting NCT05790642 - Comparison of Different Non-invasive Methods to Assess Pulse Wave Analysis
Recruiting NCT04833712 - Stereotactic Radioablation for the Treatment of Refractory Atrial Fibrillation N/A