Monitoring of Arrhythmias in Patients Treated With Antipsychotics

Arrythmia Clinical Trial

— MAPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04575103
• Other study ID #: A0001
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2021
• Source: Herlev and Gentofte Hospital
• Contact: Casper N Bang, MD, PhD
• Phone: +4538635000
• Email: casper.niels.furbo.bang[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Drug:
• Antipsychotic
Antipsychotic treatment >0.5 DDD

Locations

Country	Name	City	State
Denmark	Department of Psychiatry, Region of Southern Denmark	Aabenraa
Denmark	Cardiology, Aalborg Universitetshospital	Aalborg
Denmark	Psychiatry, Aalborg University Hospital	Aalborg
Denmark	Aarhus Universitetshospital, Skejby, Department of Cardiology	Aarhus
Denmark	Department of Psychiatry, Aarhus University	Aarhus
Denmark	Bispebjerg Hospital, Department of Cardiology	Copenhagen
Denmark	Copenhagen Center of Psychiatry (Rigshospitalet)	Copenhagen
Denmark	Mental Health Center Amager	Copenhagen
Denmark	Rigshospitalet, Department of Cardiology	Copenhagen
Denmark	Mental Health Center Frederiksberg	Frederiksberg
Denmark	Gentofte-Herlev Hospital, Department of Cardiology	Gentofte
Denmark	Mental Health Center Glostrup	Glostrup
Denmark	Mental Health Center Copenhagen	Hellerup
Denmark	North Zealand Hospital, Department of Cardiology	Hillerød
Denmark	North Zealand Hospital, Department of Psychiatry	Hillerød
Denmark	Odense University Hospital, Department of Cardiology	Odense
Denmark	Zealand University Hospital, Department of Cardiology	Roskilde
Denmark	Psychiatric Research Unit, Region of Zealand	Slagelse

Sponsors (9)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	Aalborg University Hospital, Aarhus University Hospital, Bispebjerg Hospital, Nordsjaellands Hospital, Odense University Hospital, Rigshospitalet, Denmark, University Hospital, Gentofte, Copenhagen, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long QT interval	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
Other	Pacemaker/ICD implantation.	Number of patients who receives pacemaker/ICD implantation using questionnaire and national pace- and ICD register.	2 years from insertion og loop recorder
Other	Sudden cardiac death.	Number of patients who experiences sudden cardiac death using national death and diagnosis register.	2 years from insertion og loop recorder
Other	Cardiovascular mortality	Number of patients who experiences cardiovascular mortality using national death and diagnosis register.	2 years from insertion og loop recorder
Other	All-cause mortality	Number of patients who experiences all-cause mortality using national death and diagnosis register.	2 years from insertion og loop recorder
Other	Suicide or death caused by non-cardiac factors	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
Other	Frequency of primary endpoint in controls	Frequency of primary endpoint in controls detected on insertable loop recorder.	2 years from insertion og loop recorder
Other	Frequency of primary endpoint related to specific psychiatric drugs / dose	Frequency of primary endpoint related to specific psychiatric drugs / dose detected on insertable loop recorder	2 years from insertion og loop recorder
Other	Frequency of primary endpoint related to the presence of long QTc interval	Frequency of primary endpoint related to the presence of long QTc interval detected on insertable loop recorder	2 years from insertion og loop recorder
Other	Frequency of primary endpoint in poor metabolizers compared to normal metabolizers	Frequency of primary endpoint in poor metabolizers compared to normal metabolizers detected on insertable loop recorder	2 years from insertion og loop recorder
Other	Frequency of primary endpoint by genetic analysis	Frequency of primary endpoint by genetic analysis detected on insertable loop recorder.	2 years from insertion og loop recorder
Primary	Ventricular arrhythmias	Number of patients with ventricular arrhythmias detected on insertable loop recorder	2 years from insertion og loop recorder
Secondary	Supraventricular arrhythmias	Number of patients with supraventricular arrhythmias including atrial fibrillation or flutter detected on insertable loop recorder.	2 years from insertion og loop recorder
Secondary	Bradycardia	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