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Monitoring of Arrhythmias in Patients Treated With Antipsychotics (MAPP)

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Antipsychotic
Sponsored by
Herlev and Gentofte Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Death, Sudden, Cardiac

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Department of Psychiatry, Region of Southern Denmark
  • Cardiology, Aalborg Universitetshospital
  • Psychiatry, Aalborg University Hospital
  • Aarhus Universitetshospital, Skejby, Department of Cardiology
  • Department of Psychiatry, Aarhus University
  • Bispebjerg Hospital, Department of CardiologyRecruiting
  • Copenhagen Center of Psychiatry (Rigshospitalet)
  • Mental Health Center AmagerRecruiting
  • Rigshospitalet, Department of Cardiology
  • Mental Health Center Frederiksberg
  • Gentofte-Herlev Hospital, Department of Cardiology
  • Mental Health Center Glostrup
  • Mental Health Center Copenhagen
  • North Zealand Hospital, Department of Cardiology
  • North Zealand Hospital, Department of Psychiatry
  • Odense University Hospital, Department of Cardiology
  • Zealand University Hospital, Department of Cardiology
  • Psychiatric Research Unit, Region of Zealand

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Antipsychotics

Control

Arm Description

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

Healthy controls, not treated with antipsychotics.

Outcomes

Primary Outcome Measures

Ventricular arrhythmias
Number of patients with ventricular arrhythmias detected on insertable loop recorder

Secondary Outcome Measures

Supraventricular arrhythmias
Number of patients with supraventricular arrhythmias including atrial fibrillation or flutter detected on insertable loop recorder.
Bradycardia
Number of patients with bradycardia (defined as resting rate lower than 40/min) detected on insertable loop recorder.

Full Information

First Posted
September 24, 2020
Last Updated
February 17, 2021
Sponsor
Herlev and Gentofte Hospital
Collaborators
Rigshospitalet, Denmark, Bispebjerg Hospital, Nordsjaellands Hospital, University Hospital, Gentofte, Copenhagen, Zealand University Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04575103
Brief Title
Monitoring of Arrhythmias in Patients Treated With Antipsychotics
Acronym
MAPP
Official Title
Monitoring of Arrhythmias in Patients Treated With Antipsychotics - The MAPP II Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital
Collaborators
Rigshospitalet, Denmark, Bispebjerg Hospital, Nordsjaellands Hospital, University Hospital, Gentofte, Copenhagen, Zealand University Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Death, Sudden, Cardiac, Arrythmia, Antipsychotics and Neuroleptics Toxicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antipsychotics
Arm Type
Active Comparator
Arm Description
Patients treated with antipsychotics as provided by their psychiatrist in order to treat disease best possible and in accordance with guidelines.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Healthy controls, not treated with antipsychotics.
Intervention Type
Drug
Intervention Name(s)
Antipsychotic
Intervention Description
Antipsychotic treatment >0.5 DDD
Primary Outcome Measure Information:
Title
Ventricular arrhythmias
Description
Number of patients with ventricular arrhythmias detected on insertable loop recorder
Time Frame
2 years from insertion og loop recorder
Secondary Outcome Measure Information:
Title
Supraventricular arrhythmias
Description
Number of patients with supraventricular arrhythmias including atrial fibrillation or flutter detected on insertable loop recorder.
Time Frame
2 years from insertion og loop recorder
Title
Bradycardia
Description
Number of patients with bradycardia (defined as resting rate lower than 40/min) detected on insertable loop recorder.
Time Frame
2 years from insertion og loop recorder
Other Pre-specified Outcome Measures:
Title
Long QT interval
Description
Number of patients with long QT interval on routine ECG or detected on insertable loop recorder defined as QTc > 500 ms.
Time Frame
2 years from insertion og loop recorder
Title
Pacemaker/ICD implantation.
Description
Number of patients who receives pacemaker/ICD implantation using questionnaire and national pace- and ICD register.
Time Frame
2 years from insertion og loop recorder
Title
Sudden cardiac death.
Description
Number of patients who experiences sudden cardiac death using national death and diagnosis register.
Time Frame
2 years from insertion og loop recorder
Title
Cardiovascular mortality
Description
Number of patients who experiences cardiovascular mortality using national death and diagnosis register.
Time Frame
2 years from insertion og loop recorder
Title
All-cause mortality
Description
Number of patients who experiences all-cause mortality using national death and diagnosis register.
Time Frame
2 years from insertion og loop recorder
Title
Suicide or death caused by non-cardiac factors
Description
Number of patients who experiences suicide or death caused by non-cardiac factors using national death and diagnosis register.
Time Frame
2 years from insertion og loop recorder
Title
Frequency of primary endpoint in controls
Description
Frequency of primary endpoint in controls detected on insertable loop recorder.
Time Frame
2 years from insertion og loop recorder
Title
Frequency of primary endpoint related to specific psychiatric drugs / dose
Description
Frequency of primary endpoint related to specific psychiatric drugs / dose detected on insertable loop recorder
Time Frame
2 years from insertion og loop recorder
Title
Frequency of primary endpoint related to the presence of long QTc interval
Description
Frequency of primary endpoint related to the presence of long QTc interval detected on insertable loop recorder
Time Frame
2 years from insertion og loop recorder
Title
Frequency of primary endpoint in poor metabolizers compared to normal metabolizers
Description
Frequency of primary endpoint in poor metabolizers compared to normal metabolizers detected on insertable loop recorder
Time Frame
2 years from insertion og loop recorder
Title
Frequency of primary endpoint by genetic analysis
Description
Frequency of primary endpoint by genetic analysis detected on insertable loop recorder.
Time Frame
2 years from insertion og loop recorder

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casper N Bang, MD, PhD
Phone
+4538635000
Email
casper.niels.furbo.bang@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Gunnar H Gislason, MD, PhD
Email
gunnar.gislason@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Casper Bang, MD, PhD
Organizational Affiliation
Department of Cardiology, Bispebjerg and Frederiksberg Hospital, Copenhagen University, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Region of Southern Denmark
City
Aabenraa
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikkel Højlund, MD
Email
mikkel.hojlund2@rsyd.dk
Facility Name
Cardiology, Aalborg Universitetshospital
City
Aalborg
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob M Larsen, MD
Email
jaml@rn.dk
Facility Name
Psychiatry, Aalborg University Hospital
City
Aalborg
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
René E Nielsen, MD, PhD
Email
ren@rn.dk
Facility Name
Aarhus Universitetshospital, Skejby, Department of Cardiology
City
Aarhus
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik K Jensen, DMSc, PhD
Email
hkjensen@clin.au.dk
Facility Name
Department of Psychiatry, Aarhus University
City
Aarhus
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ole Mors, MD, PhD
Email
ole.mors@clin.au.dk
Facility Name
Bispebjerg Hospital, Department of Cardiology
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Søren Højberg, MD, PhD
Email
Soeren.Hoejberg@regionh.dk
Facility Name
Copenhagen Center of Psychiatry (Rigshospitalet)
City
Copenhagen
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Fink-Jensen, MD, DMSc
Email
anders.fink-jensen@regionh.dk
Facility Name
Mental Health Center Amager
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Nordgaard, MD, PhD
Email
julie.nordgaard.frederiksen@regionh.dk
Facility Name
Rigshospitalet, Department of Cardiology
City
Copenhagen
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berit Philbert, MD, PhD
Email
berit.thornvig.philbert@regionh.dk
Facility Name
Mental Health Center Frederiksberg
City
Frederiksberg
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Runa I Munker, MD
Email
runa.munkner@regionh.dk
Facility Name
Gentofte-Herlev Hospital, Department of Cardiology
City
Gentofte
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tommi B Lindhardt, MD, PhD
Email
Tommi.bo.lindhardt@regionh.dk
Facility Name
Mental Health Center Glostrup
City
Glostrup
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casper B Westergaard, MD
Email
casper.buchardt.westergaard@regionh.dk
Facility Name
Mental Health Center Copenhagen
City
Hellerup
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merete Nordentoft, MD, DMSc
Email
merete.nordentoft@regionh.dk
Facility Name
North Zealand Hospital, Department of Cardiology
City
Hillerød
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael D Jacobsen, MD
Email
michael.dilou.jacobsen.01@regionh.dk
Facility Name
North Zealand Hospital, Department of Psychiatry
City
Hillerød
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Hechmann, MD
Email
charlotte.hechmann@regionh.dk
Facility Name
Odense University Hospital, Department of Cardiology
City
Odense
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stine O Poulsen, MD
Email
Stine.Odgaard.Poulsen1@rsyd.dk
Facility Name
Zealand University Hospital, Department of Cardiology
City
Roskilde
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas M Mechior, MD, PhD
Email
tmme@regionsjaelland.dk
Facility Name
Psychiatric Research Unit, Region of Zealand
City
Slagelse
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Simonsen, MD, PhD
Email
es@regionsjaelland.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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Monitoring of Arrhythmias in Patients Treated With Antipsychotics

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