Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-01 @ 6:51 PM
Study NCT ID:
NCT04537104
Status:
UNKNOWN
Last Update Posted:
2021-01-14
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Monitoring in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New-onset arrhythmias', 'timeFrame': '3 months', 'description': 'Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings'}], 'secondaryOutcomes': [{'measure': 'Patient compliance', 'timeFrame': 'Week 8', 'description': 'Patient compliance with at least two daily recordings.'}, {'measure': 'Patient self-reported health', 'timeFrame': '3 months', 'description': 'Patient self-reported health assessed by KCCQ.'}, {'measure': 'Patient-reported outcomes', 'timeFrame': '3 months', 'description': "Patients' response to technology and experience using the device assessed by self-developed questionnaire."}, {'measure': 'Assessing recordings', 'timeFrame': '3 months', 'description': 'Where there are interpretations of arrhythmias on recordings, agreement of recordings with subsequent Holter monitoring will be assessed.'}, {'measure': 'Subsequent prescriptions', 'timeFrame': '3 years', 'description': 'Through linkage with nationwide health care databases, subsequent prescription patterns of diuretics and antithrombotic medication in patients with and without atrial fibrillation.'}, {'measure': 'Subsequent implantations', 'timeFrame': '3 years', 'description': 'Through linkage with nationwide health care databases, subsequent implantation of cardiac devices in patients with and without atrial fibrillation.'}, {'measure': 'Subsequent readmissions', 'timeFrame': '3 years', 'description': 'Through linkage with nationwide health care databases, subsequent readmissions to hospital in patients with and without atrial fibrillation.'}, {'measure': 'All-cause mortality', 'timeFrame': '3 years', 'description': 'Through linkage with nationwide health care databases, all-cause mortality in patients with and without atrial fibrillation.'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '3 years', 'description': 'Through linkage with nationwide health care databases, cardiovascular mortality in patients with and without atrial fibrillation.'}, {'measure': 'Admissions for worsening heart failure', 'timeFrame': '3 years', 'description': 'Through linkage with nationwide health care databases, and admission for worsening heart failure in patients with and without atrial fibrillation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['arrhythmias', 'heart failure', 'remote monitoring'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed heart failure patients \\> 18 years of age from heart failure clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Owns or has access to a smartphone\n* Newly diagnosed moderate to severe heart failure (NYHA II-IV and left ventricular ejection fraction ≤ 40%)\n\nExclusion Criteria:\n\n* Earlier atrial fibrillation/atrial flutter with indication for oral anticoagulant (OAC) treatment\n* Pacemaker\n* Cardiac resynchronization device\n* Indications for OAC treatment (also low molecular weight heparin) due to atrial arrhythmias, mechanical heart valve, deep vein thrombosis, or pulmonary embolism.\n* Expected survival ≤ 6 months\n* Absolute contraindications for starting OAC treatment'}, 'identificationModule': {'nctId': 'NCT04537104', 'acronym': 'REM-HF', 'briefTitle': 'Remote Monitoring in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Herlev and Gentofte Hospital'}, 'officialTitle': 'Investigating Arrhythmias in a High-risk Population With Heart Failure Using Remote Monitoring (Coala Heart Monitor)', 'orgStudyIdInfo': {'id': 'P-2020-551'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Coala Heart Monitor', 'type': 'DEVICE', 'description': 'ECG monitoring'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Copenhagen', 'state': 'Hellerup', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Morten Kjøbæk Lamberts, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Department of Cardiology, Herlev & Gentofte Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Morten Kjøbek Lamberts, MD, PhD', 'role': 'CONTACT', 'email': 'morten.kjoebek.lamberts@regionh.dk', 'phone': '+4522434186'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev and Gentofte Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coala Life, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor and Research Director', 'investigatorFullName': 'Morten Lamberts', 'investigatorAffiliation': 'Herlev and Gentofte Hospital'}}}}