Investigating Arrhythmias in a High-risk Population With Heart Failure Using Remote Monitoring (Coala Heart Monitor)
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- New-onset arrhythmias
研究概览
简要总结
This study is a prospective cohort study with consecutive enrollment of newly diagnosed heart failure patients, investigating the prevalence and types of arrhythmias in this high-risk population using non-invasive remote monitoring with the Coala Heart Monitor. Participants are scheduled to use the Coala Heart Monitor twice daily or during symptoms (e.g. syncope, presyncope, palpitations, chest discomfort, or shortness of breath) to record a thumb and chest ECG over 3 months. Patient compliance with the recordings, self-reported health, response to technology, and experience using the device will additionally be assessed by self-developed questionnaires and the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 3 months.
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
- •Owns or has access to a smartphone
- •Newly diagnosed moderate to severe heart failure (NYHA II-IV and left ventricular ejection fraction ≤ 40%)
排除标准
- •Earlier atrial fibrillation/atrial flutter with indication for oral anticoagulant (OAC) treatment
- •Pacemaker
- •Cardiac resynchronization device
- •Indications for OAC treatment (also low molecular weight heparin) due to atrial arrhythmias, mechanical heart valve, deep vein thrombosis, or pulmonary embolism.
- •Expected survival ≤ 6 months
- •Absolute contraindications for starting OAC treatment
结局指标
主要结局
New-onset arrhythmias
时间窗: 3 months
Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings
次要结局
- Patient compliance(Week 8)
- Patient-reported outcomes(3 months)
- Subsequent implantations(3 years)
- Patient self-reported health(3 months)
- Admissions for worsening heart failure(3 years)
- Subsequent prescriptions(3 years)
- Assessing recordings(3 months)
- Cardiovascular mortality(3 years)
- Subsequent readmissions(3 years)
- All-cause mortality(3 years)
研究者
Morten Lamberts
Associate Professor and Research Director
Herlev and Gentofte Hospital