Remote Monitoring in Patients With Heart Failure
REM-HF
Investigating Arrhythmias in a High-risk Population With Heart Failure Using Remote Monitoring (Coala Heart Monitor)
1 other identifier
observational
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
September 3, 2020
CompletedStudy Start
First participant enrolled
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedJanuary 14, 2021
January 1, 2021
11 months
August 26, 2020
January 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
New-onset arrhythmias
Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings
3 months
Secondary Outcomes (10)
Patient compliance
Week 8
Patient self-reported health
3 months
Patient-reported outcomes
3 months
Assessing recordings
3 months
Subsequent prescriptions
3 years
- +5 more secondary outcomes
Interventions
ECG monitoring
Eligibility Criteria
Newly diagnosed heart failure patients \> 18 years of age from heart failure clinic
You may qualify if:
- Owns or has access to a smartphone
- Newly diagnosed moderate to severe heart failure (NYHA II-IV and left ventricular ejection fraction ≤ 40%)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev and Gentofte Hospitallead
- Coala Life, Inccollaborator
Study Sites (1)
Department of Cardiology, Herlev & Gentofte Hospital
Copenhagen, Hellerup, 2900, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor and Research Director
Study Record Dates
First Submitted
August 26, 2020
First Posted
September 3, 2020
Study Start
September 24, 2020
Primary Completion
September 1, 2021
Study Completion
September 1, 2023
Last Updated
January 14, 2021
Record last verified: 2021-01