Monitoring of Arrhythmias in Patients Treated With Antipsychotics (MAPP)
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| ClinicalTrials.gov Identifier: NCT04575103 |
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Recruitment Status :
Recruiting
First Posted : October 5, 2020
Last Update Posted : February 21, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Death, Sudden, Cardiac Arrythmia Antipsychotics and Neuroleptics Toxicity | Drug: Antipsychotic | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Monitoring of Arrhythmias in Patients Treated With Antipsychotics - The MAPP II Study |
| Actual Study Start Date : | January 1, 2021 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2024 |
| Arm | Intervention/treatment |
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Active Comparator: Antipsychotics
Patients treated with antipsychotics as provided by their psychiatrist in order to treat disease best possible and in accordance with guidelines.
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Drug: Antipsychotic
Antipsychotic treatment >0.5 DDD |
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No Intervention: Control
Healthy controls, not treated with antipsychotics.
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- Ventricular arrhythmias [ Time Frame: 2 years from insertion og loop recorder ]Number of patients with ventricular arrhythmias detected on insertable loop recorder
- 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.
- 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.
- 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.
- 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.
- 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.
- Cardiovascular mortality [ Time Frame: 2 years from insertion og loop recorder ]Number of patients who experiences cardiovascular mortality using national death and diagnosis register.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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.
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04575103
| Contact: Casper N Bang, MD, PhD | +4538635000 | casper.niels.furbo.bang@regionh.dk | |
| Contact: Gunnar H Gislason, MD, PhD | gunnar.gislason@regionh.dk |
Show 18 study locations
| Principal Investigator: | Casper Bang, MD, PhD | Department of Cardiology, Bispebjerg and Frederiksberg Hospital, Copenhagen University, Denmark |
| Responsible Party: | Casper N. Bang, Principal Investigator, University Hospital Bispebjerg and Frederiksberg |
| ClinicalTrials.gov Identifier: | NCT04575103 |
| Other Study ID Numbers: |
A0001 |
| First Posted: | October 5, 2020 Key Record Dates |
| Last Update Posted: | February 21, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Arrhythmias, Cardiac Death, Sudden, Cardiac Death, Sudden Heart Diseases Cardiovascular Diseases Pathologic Processes Death |
Heart Arrest Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |