Monitoring of Arrhythmias in Patients Treated With Antipsychotics

NCT04575103 | Unknown DMC

• 1 other identifier: A0001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 18

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Ventricular arrhythmias

  Number of patients with ventricular arrhythmias detected on insertable loop recorder

  2 years from insertion og loop recorder

Secondary Outcomes (2)

• Supraventricular arrhythmias

  2 years from insertion og loop recorder

• Bradycardia

  2 years from insertion og loop recorder

Other Outcomes (11)

• Long QT interval

  2 years from insertion og loop recorder

• Pacemaker/ICD implantation.

  2 years from insertion og loop recorder

• Sudden cardiac death.

  2 years from insertion og loop recorder

Study Arms (2)

Antipsychotics

ACTIVE COMPARATOR

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

Drug: Antipsychotic

Control

NO INTERVENTION

Healthy controls, not treated with antipsychotics.

Interventions

Antipsychotic DRUG

Antipsychotic treatment \>0.5 DDD

Antipsychotics

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Bispebjerg Hospital: collaborator
• Nordsjaellands Hospital: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator
• Zealand University Hospital: collaborator
• Odense University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator

Study Sites (18)

Department of Psychiatry, Region of Southern Denmark

Aabenraa, Denmark

NOT YET RECRUITING

Cardiology, Aalborg Universitetshospital

Aalborg, Denmark

NOT YET RECRUITING

Psychiatry, Aalborg University Hospital

Aalborg, Denmark

NOT YET RECRUITING

Aarhus Universitetshospital, Skejby, Department of Cardiology

Aarhus, Denmark

NOT YET RECRUITING

Department of Psychiatry, Aarhus University

Aarhus, Denmark

NOT YET RECRUITING

Bispebjerg Hospital, Department of Cardiology

Copenhagen, Denmark

RECRUITING

Copenhagen Center of Psychiatry (Rigshospitalet)

Copenhagen, Denmark

NOT YET RECRUITING

Mental Health Center Amager

Copenhagen, Denmark

RECRUITING

Rigshospitalet, Department of Cardiology

Copenhagen, Denmark

NOT YET RECRUITING

Mental Health Center Frederiksberg

Frederiksberg, Denmark

NOT YET RECRUITING

Gentofte-Herlev Hospital, Department of Cardiology

Gentofte Municipality, Denmark

NOT YET RECRUITING

Mental Health Center Glostrup

Glostrup Municipality, Denmark

NOT YET RECRUITING

Mental Health Center Copenhagen

Hellerup, Denmark

NOT YET RECRUITING

North Zealand Hospital, Department of Cardiology

Hillerød, Denmark

NOT YET RECRUITING

North Zealand Hospital, Department of Psychiatry

Hillerød, Denmark

NOT YET RECRUITING

Odense University Hospital, Department of Cardiology

Odense, Denmark

NOT YET RECRUITING

Zealand University Hospital, Department of Cardiology

Roskilde, Denmark

NOT YET RECRUITING

Psychiatric Research Unit, Region of Zealand

Slagelse, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Death, Sudden, Cardiac; Arrhythmias, Cardiac

Interventions

Antipsychotic Agents

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Officials

• Casper Bang, MD, PhD

  Department of Cardiology, Bispebjerg and Frederiksberg Hospital, Copenhagen University, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casper N Bang, MD, PhD

CONTACT

+4538635000; casper.niels.furbo.bang@regionh.dk

Gunnar H Gislason, MD, PhD

CONTACT

gunnar.gislason@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 5, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (18)