Monitoring of Arrhythmias in Patients Treated With Antipsychotics
NCT ID: NCT04575103
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2021-01-01
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Antipsychotics
Patients treated with antipsychotics as provided by their psychiatrist in order to treat disease best possible and in accordance with guidelines.
Antipsychotic
Antipsychotic treatment \>0.5 DDD
Control
Healthy controls, not treated with antipsychotics.
No interventions assigned to this group
Interventions
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Antipsychotic
Antipsychotic treatment \>0.5 DDD
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
50 Years
ALL
Yes
Sponsors
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Rigshospitalet, Denmark
OTHER
Bispebjerg Hospital
OTHER
Nordsjaellands Hospital
OTHER
University Hospital, Gentofte, Copenhagen
OTHER
Zealand University Hospital
OTHER
Odense University Hospital
OTHER
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Herlev and Gentofte Hospital
OTHER
Responsible Party
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Casper N. Bang
Principal Investigator
Principal Investigators
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Casper Bang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Bispebjerg and Frederiksberg Hospital, Copenhagen University, Denmark
Locations
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Department of Psychiatry, Region of Southern Denmark
Aabenraa, , Denmark
Cardiology, Aalborg Universitetshospital
Aalborg, , Denmark
Psychiatry, Aalborg University Hospital
Aalborg, , Denmark
Aarhus Universitetshospital, Skejby, Department of Cardiology
Aarhus, , Denmark
Department of Psychiatry, Aarhus University
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 Municipality, , Denmark
Mental Health Center Glostrup
Glostrup Municipality, , Denmark
Mental Health Center Copenhagen
Hellerup, , Denmark
North Zealand Hospital, Department of Cardiology
Hillerød, , Denmark
North Zealand Hospital, Department of Psychiatry
Hillerød, , Denmark
Odense University Hospital, Department of Cardiology
Odense, , Denmark
Zealand University Hospital, Department of Cardiology
Roskilde, , Denmark
Psychiatric Research Unit, Region of Zealand
Slagelse, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Julie Nordgaard, MD, PhD
Role: primary
Role: backup
Casper B Westergaard, MD
Role: primary
Role: backup
Other Identifiers
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A0001
Identifier Type: -
Identifier Source: org_study_id
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