Remote Monitoring in Patients With Heart Failure

Heart Failure Clinical Trial

— REM-HF  

Official title:

Investigating Arrhythmias in a High-risk Population With Heart Failure Using Remote Monitoring (Coala Heart Monitor)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537104
• Other study ID #: P-2020-551
• Status: Recruiting
• Start date: September 24, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2021
• Source: Herlev and Gentofte Hospital
• Contact: Morten Kjøbek Lamberts, MD, PhD
• Phone: +4522434186
• Email: morten.kjoebek.lamberts[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Coala Heart Monitor
ECG monitoring

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Herlev & Gentofte Hospital	Copenhagen	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	Coala Life, Inc

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New-onset arrhythmias	Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings	3 months
Secondary	Patient compliance	Patient compliance with at least two daily recordings.	Week 8
Secondary	Patient self-reported health	Patient self-reported health assessed by KCCQ.	3 months
Secondary	Patient-reported outcomes	Patients' response to technology and experience using the device assessed by self-developed questionnaire.	3 months
Secondary	Assessing recordings	Where there are interpretations of arrhythmias on recordings, agreement of recordings with subsequent Holter monitoring will be assessed.	3 months
Secondary	Subsequent prescriptions	Through linkage with nationwide health care databases, subsequent prescription patterns of diuretics and antithrombotic medication in patients with and without atrial fibrillation.	3 years
Secondary	Subsequent implantations	Through linkage with nationwide health care databases, subsequent implantation of cardiac devices in patients with and without atrial fibrillation.	3 years
Secondary	Subsequent readmissions	Through linkage with nationwide health care databases, subsequent readmissions to hospital in patients with and without atrial fibrillation.	3 years
Secondary	All-cause mortality	Through linkage with nationwide health care databases, all-cause mortality in patients with and without atrial fibrillation.	3 years
Secondary	Cardiovascular mortality	Through linkage with nationwide health care databases, cardiovascular mortality in patients with and without atrial fibrillation.	3 years
Secondary	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.	3 years