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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Herlev and Gentofte Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Odense University Hospital
Zealand University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Bispebjerg Hospital
Aalborg University Hospital
University Hospital, Gentofte, Copenhagen
Nordsjaellands Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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