Investigating Arrhythmias in a High-risk Population With Heart Failure Using Remote Monitoring (Coala Heart Monitor)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Herlev and Gentofte Hospital
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- New-onset arrhythmias
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Morten Lamberts
Associate Professor and Research Director
Herlev and Gentofte Hospital
Eligibility Criteria
Inclusion Criteria
- •Owns or has access to a smartphone
- •Newly diagnosed moderate to severe heart failure (NYHA II-IV and left ventricular ejection fraction ≤ 40%)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
New-onset arrhythmias
Time Frame: 3 months
Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings
Secondary Outcomes
- 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)