Heart FailureREM-HFNCT04537104
Remote Monitoring in Patients With Heart Failure
An observational study of Heart Failure, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Coala Heart Monitor
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Sep 2020to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed heart failure patients > 18 years of age from heart failure clinic
Who may be able to join
- Owns or has access to a smartphone
- Newly diagnosed moderate to severe heart failure (NYHA II-IV and left ventricular ejection fraction ≤ 40%)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Cardiology, Herlev & Gentofte Hospital
Copenhagen, Hellerup, 2900
Morten Kjøbæk Lamberts, MD, PhD
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Coala Heart Monitor
- Keywords
- arrhythmias, heart failure, remote monitoring
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coala Heart MonitorDevice
ECG monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
New-onset arrhythmias
Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings
Measured: 3 months
Secondary outcomes (10)
Patient compliance
Patient compliance with at least two daily recordings.
Measured: Week 8
Patient self-reported health
Patient self-reported health assessed by KCCQ.
Measured: 3 months
Patient-reported outcomes
Patients' response to technology and experience using the device assessed by self-developed questionnaire.
Measured: 3 months
Assessing recordings
Where there are interpretations of arrhythmias on recordings, agreement of recordings with subsequent Holter monitoring will be assessed.
Measured: 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.
Measured: 3 years
Subsequent implantations
Through linkage with nationwide health care databases, subsequent implantation of cardiac devices in patients with and without atrial fibrillation.
Measured: 3 years
Subsequent readmissions
Through linkage with nationwide health care databases, subsequent readmissions to hospital in patients with and without atrial fibrillation.
Measured: 3 years
All-cause mortality
Through linkage with nationwide health care databases, all-cause mortality in patients with and without atrial fibrillation.
Measured: 3 years
Cardiovascular mortality
Through linkage with nationwide health care databases, cardiovascular mortality in patients with and without atrial fibrillation.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start24 Sep 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Coala Life, Inc
- Responsible party
- Principal investigator, Morten Lamberts, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537104
- Sponsor's protocol ID
- P-2020-551
- Acronym
- REM-HF
- Status last verified
- Jan 2021
- First submitted
- 26 Aug 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Arrhythmias in a High-risk Population With Heart Failure Using Remote Monitoring (Coala Heart Monitor)
- ClinicalTrials.gov ID
- NCT04537104
- Acronym / sponsor ID
- REM-HF / P-2020-551
- Conditions
- Heart Failure
- Keywords
- arrhythmias, heart failure, remote monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Coala Life, Inc
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed heart failure patients > 18 years of age from heart failure clinic
Key inclusion criteria (2 listed)
- Owns or has access to a smartphone
- Newly diagnosed moderate to severe heart failure (NYHA II-IV and left ventricular ejection fraction ≤ 40%)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coala Heart MonitorECG monitoring | Device | – |
Primary outcome
New-onset arrhythmias
Time frame: 3 months
Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings
10 secondary outcomes
Patient compliance
Time frame: Week 8
Patient self-reported health
Time frame: 3 months
Patient-reported outcomes
Time frame: 3 months
Assessing recordings
Time frame: 3 months
Subsequent prescriptions
Time frame: 3 years
Subsequent implantations
Time frame: 3 years
Subsequent readmissions
Time frame: 3 years
All-cause mortality
Time frame: 3 years
Cardiovascular mortality
Time frame: 3 years
Admissions for worsening heart failure
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morten Kjøbek Lamberts, MD, PhD (+4522434186, morten.kjoebek.lamberts@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New-onset arrhythmias (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.