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)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Coala Heart Monitor

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

• Study Contact: Name: Morten Kjøbek Lamberts, MD, PhD; Phone Number: +4522434186; Email: morten.kjoebek.lamberts@regionh.dk

Study Locations

• Denmark
  • Hellerup
    • Copenhagen, Hellerup, Denmark, 2900
      • Recruiting
      • Department of Cardiology, Herlev & Gentofte Hospital
      • Contact: Morten Kjøbæk Lamberts, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed heart failure patients > 18 years of age from heart failure clinic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New-onset arrhythmias	Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Collaborators: Coala Life, Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: heart failure; remote monitoring; arrhythmias
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: P-2020-551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No