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临床试验/NCT04575103
NCT04575103招募中不适用

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

Herlev and Gentofte Hospital18 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
18
主要终点
Ventricular arrhythmias

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

Antipsychotics

Active Comparator

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

干预措施: Antipsychotic (Drug)

结局指标

主要结局

Ventricular arrhythmias

时间窗: 2 years from insertion og loop recorder

Number of patients with ventricular arrhythmias detected on insertable loop recorder

次要结局

  • Supraventricular arrhythmias(2 years from insertion og loop recorder)
  • Bradycardia(2 years from insertion og loop recorder)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Casper N. Bang

Principal Investigator

University Hospital Bispebjerg and Frederiksberg

研究点 (18)

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