Coffee Use, Physical Activity and Symptomatic Ventricular Arrhythmias in Patients With Left Ventricular Dysfunction and an ICD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Burden of premature ventricular contractions (PVCs)
研究概览
简要总结
The goal of this observational study is to learn whether caffeine consumption is associated with ventricular arrhythmias and physical activity in adults with heart failure, reduced left ventricular ejection fraction, and an implantable cardioverter-defibrillator (ICD). The main questions it aims to answer are:
Is caffeine consumption associated with the burden of premature ventricular contractions (PVCs)? Is caffeine consumption associated with the occurrence of ventricular arrhythmias, including non-sustained ventricular tachycardia (NSVT), sustained monomorphic ventricular tachycardia (SMVT), and ventricular fibrillation (VF)? Is caffeine consumption associated with the level of daily physical activity recorded by the ICD?
Participants will:
Complete a one-time questionnaire about their consumption of coffee and other caffeine-containing products during the previous 7 days.
Allow researchers to collect relevant information from their medical records. Allow researchers to use data already collected during the routine follow-up of their ICD, including information on heart rhythm abnormalities, heart rate, and physical activity.
No additional hospital visits, medical examinations, blood tests, or changes to treatment are required as part of this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained prior to any study procedure.
- •Age ≥18 years.
- •Left ventricular systolic dysfunction (LVEF <50%), i.e. HFrEF or HFmrEF, documented on the most recent available transthoracic echocardiogram.
- •Presence of a transvenous implantable cardioverter-defibrillator (ICD), including cardiac resynchronization therapy defibrillators (CRT-D), implanted at least 12 months before the caffeine questionnaire.
排除标准
- •Presence of channelopathies.
- •Subcutaneous implantable cardioverter-defibrillator (S-ICD), which does not provide ventricular ectopic beat counters, accelerometer-derived physical activity data or antitachycardia pacing, and therefore cannot generate the primary outcome measure.
- •Inability to complete the study questionnaire on coffee and caffeinated product consumption.
结局指标
主要结局
Burden of premature ventricular contractions (PVCs)
时间窗: 12 months
Burden of premature ventricular contractions (PVCs), expressed as the percentage of total recorded ventricular beats represented by PVCs (%PVC burden), as provided by the device's remote monitoring software, assessed over the 12 months immediately preceding the date of the caffeine questionnaire, averaged across all monitored days. Unit: percent (%).
次要结局
- Non-sustained ventricular tachycardia (NSVT): occurrence (%)(12 months)
- Non-sustained ventricular tachycardia (NSVT): rate(12 months)
- Non-sustained ventricular tachycardia (NSVT): distribution(12 months)
- Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): occurrence (%)(12 months)
- Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): rate(12 months)
- Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): median episode duration (seconds)(12 months)
- Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mode of termination(12 months)
- Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mean cycle length (ms)(12 months)
- Physical activity (hours per day)(12 months)
- Physical activity: mean daily activity expressed as a z-score(12 months)
研究者
Jean-Benoît Le Polain de Waroux
Coordinating Principal Investigator
AZ Sint-Jan AV