Monitoring of Arrhythmias in Patients Treated With Antipsychotics - The MAPP II Study
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
- 是
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
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
Casper N. Bang
Principal Investigator
University Hospital Bispebjerg and Frederiksberg
