Death, Sudden, CardiacMAPPNCT04575103
Monitoring of Arrhythmias in Patients Treated With Antipsychotics
A study testing Antipsychotic in people with Death, Sudden, Cardiac and Arrythmia, run by Herlev and Gentofte Hospital at 18 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Death, Sudden, Cardiac, Arrythmia, Antipsychotics and Neuroleptics Toxicity
- What is being tested?
- Antipsychotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 18 sitesDenmark
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
18 sites in 1 country.
Gunnar H Gislason, MD, PhD contact
18 sites in 1 country
Denmark18 sites, 18 recruiting
- Not yet recruiting
Department of Psychiatry, Region of Southern Denmark
Aabenraa
Mikkel Højlund, MD, mikkel.hojlund2@rsyd.dk
- Not yet recruiting
Cardiology, Aalborg Universitetshospital
Aalborg
Jacob M Larsen, MD, jaml@rn.dk
- Not yet recruiting
Psychiatry, Aalborg University Hospital
Aalborg
René E Nielsen, MD, PhD, ren@rn.dk
- Not yet recruiting
Aarhus Universitetshospital, Skejby, Department of Cardiology
Aarhus
Henrik K Jensen, DMSc, PhD, hkjensen@clin.au.dk
- Not yet recruiting
Department of Psychiatry, Aarhus University
Aarhus
Ole Mors, MD, PhD, ole.mors@clin.au.dk
- Recruiting
Bispebjerg Hospital, Department of Cardiology
Copenhagen
Søren Højberg, MD, PhD, Soeren.Hoejberg@regionh.dk
- Not yet recruiting
Copenhagen Center of Psychiatry (Rigshospitalet)
Copenhagen
Anders Fink-Jensen, MD, DMSc, anders.fink-jensen@regionh.dk
- Recruiting
Mental Health Center Amager
Copenhagen
Julie Nordgaard, MD, PhD
julie.nordgaard.frederiksen@regionh.dk
- Not yet recruiting
Rigshospitalet, Department of Cardiology
Copenhagen
Berit Philbert, MD, PhD, berit.thornvig.philbert@regionh.dk
- Not yet recruiting
Mental Health Center Frederiksberg
Frederiksberg
Runa I Munker, MD, runa.munkner@regionh.dk
- Not yet recruiting
Gentofte-Herlev Hospital, Department of Cardiology
Gentofte Municipality
Tommi B Lindhardt, MD, PhD, Tommi.bo.lindhardt@regionh.dk
- Not yet recruiting
Mental Health Center Glostrup
Glostrup Municipality
Casper B Westergaard, MD
casper.buchardt.westergaard@regionh.dk
- Not yet recruiting
Mental Health Center Copenhagen
Hellerup
Merete Nordentoft, MD, DMSc, merete.nordentoft@regionh.dk
- Not yet recruiting
North Zealand Hospital, Department of Cardiology
Hillerød
Michael D Jacobsen, MD, michael.dilou.jacobsen.01@regionh.dk
- Not yet recruiting
North Zealand Hospital, Department of Psychiatry
Hillerød
Charlotte Hechmann, MD, charlotte.hechmann@regionh.dk
- Not yet recruiting
Odense University Hospital, Department of Cardiology
Odense
Stine O Poulsen, MD, Stine.Odgaard.Poulsen1@rsyd.dk
- Not yet recruiting
Zealand University Hospital, Department of Cardiology
Roskilde
Thomas M Mechior, MD, PhD, tmme@regionsjaelland.dk
- Not yet recruiting
Psychiatric Research Unit, Region of Zealand
Slagelse
Erik Simonsen, MD, PhD, es@regionsjaelland.dk
About this study
Official title: 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.
Read the 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.
- Being tested
- Antipsychotic
- Medical subject headings
- Death, Sudden, Cardiac, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntipsychoticDrug
Antipsychotic treatment >0.5 DDD
| Study group | Role | What they receive |
|---|---|---|
| Antipsychotics | Active comparator | Patients treated with antipsychotics as provided by their psychiatrist in order to treat disease best possible and in accordance with guidelines. Receives: Drug: Antipsychotic |
| Control | No intervention | Healthy controls, not treated with antipsychotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular arrhythmias
Number of patients with ventricular arrhythmias detected on insertable loop recorder
Measured: 2 years from insertion og loop recorder
Secondary outcomes (2)
Supraventricular arrhythmias
Number of patients with supraventricular arrhythmias including atrial fibrillation or flutter detected on insertable loop recorder.
Measured: 2 years from insertion og loop recorder
Bradycardia
Number of patients with bradycardia (defined as resting rate lower than 40/min) detected on insertable loop recorder.
Measured: 2 years from insertion og loop recorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Death, Sudden, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital, Nordsjaellands Hospital, University Hospital, Gentofte, Copenhagen, Zealand University Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital
- Responsible party
- Principal investigator, Casper N. Bang, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Casper Bang, MD, PhD, Principal investigator, Department of Cardiology, Bispebjerg and Frederiksberg Hospital, Copenhagen University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575103
- Sponsor's protocol ID
- A0001
- Acronym
- MAPP
- Status last verified
- Feb 2021
- First submitted
- 24 Sep 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Arrhythmias in Patients Treated With Antipsychotics - The MAPP II Study
- ClinicalTrials.gov ID
- NCT04575103
- Acronym / sponsor ID
- MAPP / A0001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital, Nordsjaellands Hospital, University Hospital, Gentofte, Copenhagen, Zealand University Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antipsychotics | Active comparator | Drug: AntipsychoticPatients treated with antipsychotics as provided by their psychiatrist in order to treat disease best possible and in accordance with guidelines. |
| Control | No intervention | –Healthy controls, not treated with antipsychotics. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients with SMI defined according to ICD-10 as:
- Patients treated with or initiating antipsychotics with ≥ 0.5 daily defined dosage
- >18 years old and <50 years.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntipsychoticAntipsychotic treatment >0.5 DDD | Drug | Antipsychotics |
Primary outcome
Ventricular arrhythmias
Time frame: 2 years from insertion og loop recorder
Number of patients with ventricular arrhythmias detected on insertable loop recorder
2 secondary outcomes
Supraventricular arrhythmias
Time frame: 2 years from insertion og loop recorder
Bradycardia
Time frame: 2 years from insertion og loop recorder
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar H Gislason, MD, PhD contact
Casper Bang, MD, PhD principal investigator
Department of Cardiology, Bispebjerg and Frederiksberg Hospital, Copenhagen University, Denmark
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antipsychotic in people with Death, Sudden, Cardiac and Arrythmia, run by Herlev and Gentofte Hospital at 18 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Casper N Bang, MD, PhD (+4538635000, casper.niels.furbo.bang@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular arrhythmias (time frame: 2 years from insertion og loop recorder). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.