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.
Study Type
OBSERVATIONAL
Enrollment
130
ECG monitoring
Department of Cardiology, Herlev & Gentofte Hospital
Copenhagen, Hellerup, Denmark
RECRUITINGNew-onset arrhythmias
Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings
Time frame: 3 months
Patient compliance
Patient compliance with at least two daily recordings.
Time frame: Week 8
Patient self-reported health
Patient self-reported health assessed by KCCQ.
Time frame: 3 months
Patient-reported outcomes
Patients' response to technology and experience using the device assessed by self-developed questionnaire.
Time frame: 3 months
Assessing recordings
Where there are interpretations of arrhythmias on recordings, agreement of recordings with subsequent Holter monitoring will be assessed.
Time frame: 3 months
Subsequent prescriptions
Through linkage with nationwide health care databases, subsequent prescription patterns of diuretics and antithrombotic medication in patients with and without atrial fibrillation.
Time frame: 3 years
Subsequent implantations
Through linkage with nationwide health care databases, subsequent implantation of cardiac devices in patients with and without atrial fibrillation.
Time frame: 3 years
Subsequent readmissions
Through linkage with nationwide health care databases, subsequent readmissions to hospital in patients with and without atrial fibrillation.
Time frame: 3 years
All-cause mortality
Through linkage with nationwide health care databases, all-cause mortality in patients with and without atrial fibrillation.
Time frame: 3 years
Cardiovascular mortality
Through linkage with nationwide health care databases, cardiovascular mortality in patients with and without atrial fibrillation.
Time frame: 3 years
Admissions for worsening heart failure
Through linkage with nationwide health care databases, and admission for worsening heart failure in patients with and without atrial fibrillation.
Time frame: 3 years
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