Remote Monitoring in Patients With Heart Failure (REM-HF)

Herlev and Gentofte Hospital

Status: Unknown

Conditions: Heart Failure

Treatments: Device: Coala Heart Monitor

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04537104

P-2020-551

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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