Remote Monitoring in Patients With Heart Failure

• Conditions: Heart Failure

• Registration Number: NCT04537104
• Lead Sponsor: Herlev and Gentofte Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-03
• Study Start: 2020-09-24
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14
• Primary Completion: 2021-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
New-onset arrhythmias	3 months	Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings

Secondary Outcome Measures

Name	Time	Method
Patient compliance	Week 8	Patient compliance with at least two daily recordings.
Patient-reported outcomes	3 months	Patients' response to technology and experience using the device assessed by self-developed questionnaire.
Subsequent implantations	3 years	Through linkage with nationwide health care databases, subsequent implantation of cardiac devices in patients with and without atrial fibrillation.
Patient self-reported health	3 months	Patient self-reported health assessed by KCCQ.
Admissions for worsening heart failure	3 years	Through linkage with nationwide health care databases, and admission for worsening heart failure in patients with and without atrial fibrillation.
Subsequent prescriptions	3 years	Through linkage with nationwide health care databases, subsequent prescription patterns of diuretics and antithrombotic medication in patients with and without atrial fibrillation.
Assessing recordings	3 months	Where there are interpretations of arrhythmias on recordings, agreement of recordings with subsequent Holter monitoring will be assessed.
Cardiovascular mortality	3 years	Through linkage with nationwide health care databases, cardiovascular mortality in patients with and without atrial fibrillation.
Subsequent readmissions	3 years	Through linkage with nationwide health care databases, subsequent readmissions to hospital in patients with and without atrial fibrillation.
All-cause mortality	3 years	Through linkage with nationwide health care databases, all-cause mortality in patients with and without atrial fibrillation.

Trial Locations

Locations (1)

Department of Cardiology, Herlev & Gentofte Hospital; 🇩🇰 Copenhagen, Hellerup, Denmark