Remote Monitoring in Patients With Heart Failure

NCT ID: NCT04537104

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-24

Study Completion Date

2023-09-01

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Coala Heart Monitor

ECG monitoring

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coala Life, Inc

INDUSTRY

Sponsor Role collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role lead

Responsible Party

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Morten Lamberts

Associate Professor and Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Cardiology, Herlev & Gentofte Hospital

Copenhagen, Hellerup, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Morten Kjøbek Lamberts, MD, PhD

Role: CONTACT

+4522434186

Facility Contacts

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Morten Kjøbæk Lamberts, MD, PhD

Role: primary

Other Identifiers

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P-2020-551

Identifier Type: -

Identifier Source: org_study_id

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