Monitoring of Arrhythmias in Patients Treated With Antipsychotics (MAPP)

February 17, 2021 updated by: Casper N. Bang, Herlev and Gentofte Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aabenraa, Denmark
        • Not yet recruiting
        • Department of Psychiatry, Region of Southern Denmark
        • Contact:
      • Aalborg, Denmark
        • Not yet recruiting
        • Cardiology, Aalborg Universitetshospital
        • Contact:
      • Aalborg, Denmark
        • Not yet recruiting
        • Psychiatry, Aalborg University Hospital
        • Contact:
      • Aarhus, Denmark
        • Not yet recruiting
        • Aarhus Universitetshospital, Skejby, Department of Cardiology
        • Contact:
      • Aarhus, Denmark
        • Not yet recruiting
        • Department of Psychiatry, Aarhus University
        • Contact:
      • Copenhagen, Denmark
      • Copenhagen, Denmark
      • Copenhagen, Denmark
      • Copenhagen, Denmark
      • Frederiksberg, Denmark
      • Gentofte, Denmark
      • Glostrup, Denmark
      • Hellerup, Denmark
      • Hillerød, Denmark
      • Hillerød, Denmark
      • Odense, Denmark
      • Roskilde, Denmark
        • Not yet recruiting
        • Zealand University Hospital, Department of Cardiology
        • Contact:
      • Slagelse, Denmark
        • Not yet recruiting
        • Psychiatric Research Unit, Region of Zealand
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventricular arrhythmias
Time Frame: 2 years from insertion og loop recorder
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
Time Frame: 2 years from insertion og loop recorder
Number of patients with supraventricular arrhythmias including atrial fibrillation or flutter detected on insertable loop recorder.
2 years from insertion og loop recorder
Bradycardia
Time Frame: 2 years from insertion og loop recorder
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long QT interval
Time Frame: 2 years from insertion og loop recorder
Number of patients with long QT interval on routine ECG or detected on insertable loop recorder defined as QTc > 500 ms.
2 years from insertion og loop recorder
Pacemaker/ICD implantation.
Time Frame: 2 years from insertion og loop recorder
Number of patients who receives pacemaker/ICD implantation using questionnaire and national pace- and ICD register.
2 years from insertion og loop recorder
Sudden cardiac death.
Time Frame: 2 years from insertion og loop recorder
Number of patients who experiences sudden cardiac death using national death and diagnosis register.
2 years from insertion og loop recorder
Cardiovascular mortality
Time Frame: 2 years from insertion og loop recorder
Number of patients who experiences cardiovascular mortality using national death and diagnosis register.
2 years from insertion og loop recorder
All-cause mortality
Time Frame: 2 years from insertion og loop recorder
Number of patients who experiences all-cause mortality using national death and diagnosis register.
2 years from insertion og loop recorder
Suicide or death caused by non-cardiac factors
Time Frame: 2 years from insertion og loop recorder
Number of patients who experiences suicide or death caused by non-cardiac factors using national death and diagnosis register.
2 years from insertion og loop recorder
Frequency of primary endpoint in controls
Time Frame: 2 years from insertion og loop recorder
Frequency of primary endpoint in controls detected on insertable loop recorder.
2 years from insertion og loop recorder
Frequency of primary endpoint related to specific psychiatric drugs / dose
Time Frame: 2 years from insertion og loop recorder
Frequency of primary endpoint related to specific psychiatric drugs / dose detected on insertable loop recorder
2 years from insertion og loop recorder
Frequency of primary endpoint related to the presence of long QTc interval
Time Frame: 2 years from insertion og loop recorder
Frequency of primary endpoint related to the presence of long QTc interval detected on insertable loop recorder
2 years from insertion og loop recorder
Frequency of primary endpoint in poor metabolizers compared to normal metabolizers
Time Frame: 2 years from insertion og loop recorder
Frequency of primary endpoint in poor metabolizers compared to normal metabolizers detected on insertable loop recorder
2 years from insertion og loop recorder
Frequency of primary endpoint by genetic analysis
Time Frame: 2 years from insertion og loop recorder
Frequency of primary endpoint by genetic analysis detected on insertable loop recorder.
2 years from insertion og loop recorder

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev and Gentofte Hospital

Collaborators

Odense University Hospital
Zealand University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Bispebjerg Hospital
Aalborg University Hospital
University Hospital, Gentofte, Copenhagen
Nordsjaellands Hospital

Investigators

  • Principal Investigator: Casper Bang, MD, PhD, Department of Cardiology, Bispebjerg and Frederiksberg Hospital, Copenhagen University, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Death, Sudden, Cardiac

Clinical Trials on Antipsychotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe