Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:17 AM
Study NCT ID:
NCT07343895
Status:
RECRUITING
Last Update Posted:
2026-01-15
First Post:
2025-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Population-based Atrial Fibrillation Screening in Individuals With NT-proBNP Above Median in the Tromsø Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-18', 'size': 369384, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-18T08:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In the planned open label randomized screening trial trial we plan to include 4000 individuals fra the 8th wave of the population based Tromsø Study with NT-proBNP above median without previous known AF or ongoing anticoagulant treatment. Participants will be randomized 1:1 to continuous ECG monitoring using the Norwegian produced ECG247 sensor. og to the control group without any monitoring of heart rythm.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2035-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with the composite outcome of ischemic stroke or cardiovascular death', 'timeFrame': 'Within 6 years of screening', 'description': 'Composite outcome of ischemic stroke and cardiovascular death'}, {'measure': 'Number of participants with ischemic stroke', 'timeFrame': 'Within 6 years of screening', 'description': 'Ischemic stroke outcome'}, {'measure': 'Number of participants with intracerebral hemorrhage', 'timeFrame': 'Within 6 years of screening', 'description': 'Intracerebral hemorrhage outcome'}, {'measure': 'Number of participants with cardiovascular death', 'timeFrame': 'Within 6 years of screening', 'description': 'Cardiovascular death outcome'}], 'secondaryOutcomes': [{'measure': 'Number of participants with atrial fibrillation', 'timeFrame': 'Within 14 days of screening', 'description': 'Atrial fibrillation prevalence'}, {'measure': 'Duration of atrial fibrillation in hours', 'timeFrame': 'Within 14 days of screening', 'description': 'Atrial fibrillation burden'}, {'measure': 'Left atrial volume index', 'timeFrame': 'Within 1 year of screening', 'description': 'Echocardiographic measure'}, {'measure': 'Left atrial reservoir strain', 'timeFrame': 'Within 1 year of screening', 'description': 'Echocardiographic measures'}, {'measure': 'Score on the 12-word immediate recall test', 'timeFrame': 'Within 6 years of screening', 'description': 'Cognitive test performance outcome'}, {'measure': 'Score on the Mini-Mental State Examination (MMS-E)', 'timeFrame': 'Within 6 years of screening', 'description': 'Cognitive test performance outcome'}, {'measure': 'Score on the digit symbol coding test', 'timeFrame': 'Within 6 years of screening', 'description': 'Cognitive test performance outcome'}, {'measure': 'Score on the HRQoL EuroQol-5 Dimension (EQ5D)', 'timeFrame': 'Within one year of screening', 'description': 'Health related quality of life (HRQoL) outcome'}, {'measure': 'Score on the Whiteley Index', 'timeFrame': 'Within one year of screening', 'description': 'Health anxiety outcome'}, {'measure': 'Global brain volume', 'timeFrame': 'Within 2.5 years of screening', 'description': 'Brain MRI measures'}, {'measure': 'Segmental brain volume', 'timeFrame': 'Within 2.5 years of screening', 'description': 'Brain MRI measures'}, {'measure': 'Volume of white matter lesions', 'timeFrame': 'Within 2.5 years of screening', 'description': 'Brain MRI measures'}, {'measure': 'Number of clinical and subclinical infarcts', 'timeFrame': 'Within 2.5 years of screening', 'description': 'Brain MRI measures'}, {'measure': 'Number og micro-hemorrhages', 'timeFrame': 'Within 2.5 years of screening', 'description': 'Brain MRI measures'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECG247', 'Atrial Fibrillation', 'Stroke', 'NT-Pro-BNP', 'Cognitive decline', 'Life Quality', 'Heart Failure'], 'conditions': ['Atrial Fibrillation (AF)', 'Stroke', 'NT-pro-BNP', 'Cognitive Function and Well-Being', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The aim is to investigate whether screening with long-term ECG monitoring in individuals with elevated NT-proBNP leads to a lower incidence of ischeamic stroke and death from vascular causes. The project is a sub-study within the 8th wave of the population based Tromsø Study. Information on previous diseases, medication use, and risk factors is collected through questionnaires, blood samples, and measurements of height, weight, blood pressure, and ECG.\n\nA total of 4,000 individuals with NT-proBNP levels above the median, without previously known atrial fibrillation (AF) or ongoing anticoagulation therapy, will be randomized to either long-term heart rhythm monitoring (7 days) or a control group without long-term ECG monitoring (2,000 in each group). Individuals with AF in the intervention group will be offered anticoagulation therapy in accordance with current guidelines.\n\nThe intervention group and the control group will be compared with regards to incident stroke and death within a 6-year follow-up period. Information on endpoints and anticoagulation use will be obtained through linkage to national registries.', 'detailedDescription': 'This project has the potential for providing new knowledge related to the benefit of a stepwise screening approach for AF according to NT-proBNP level, utilizing a novel patch monitor with continuous ECG monitoring and automatic artificial intelligence based (AI) ECG analysis. The present project is planned as a sub-study of the epidemiological population-based Tromsø Study. In a randomized controlled clinical trial, we plan to test the primary hypothesis that in individuals with elevated NT-ProBNP who are diagnosed with AF through long-term ECG monitoring, anticoagulation treatment according to international guidelines will reduce the incidence of incident ischeamic stroke and cardiovascular death in the screening group compared to individuals who do not undergo screening (control group). The study will be performed within a well-defined cohort with extensive available longitudinal and cross-sectional information on risk factors and co-existing conditions. This setup facilitates addressing several knowledge gaps concerning risk stratification including associations between AF and echocardiographic parameters, cognitive impairment, structural changes on brain MRI, and HRQoL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥40 years\n* NT-proBNP\\> median level\n* Informed consent for participation\n\nExclusion Criteria:\n\n* History of AF (self-reported)\n* Use of anticoagulation therapy\n* Pacemaker/CRT device\n* No available smart phone'}, 'identificationModule': {'nctId': 'NCT07343895', 'acronym': 'PAFS-Tromsø', 'briefTitle': 'Population-based Atrial Fibrillation Screening in Individuals With NT-proBNP Above Median in the Tromsø Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Atrial Fibrillation and Long Term ECG Monitoring of Heart Rhythm in the Tromsø Study', 'orgStudyIdInfo': {'id': '2025/856478 (REK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'A total of 2000 individuals with NT-proBNP levels above the median, without previously known atrial fibrillation (AF) or ongoing anticoagulation therapy, will be randomized long-term heart rhythm monitoring using ECG247 (5-7 days). Individuals with AF in the intervention group will be offered anticoagulation therapy in accordance with current guidelines.', 'interventionNames': ['Diagnostic Test: Long term heart rythm monitoring by ECG247']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control arm'}], 'interventions': [{'name': 'Long term heart rythm monitoring by ECG247', 'type': 'DIAGNOSTIC_TEST', 'description': 'The AF screening device will be sent by post from the study centre to participants in the intervention group at inclusion, free-of-charge. User guides and a "help-desk" located at the University Hospital of North Norway will be available for phone/video assistance. Continuous ECG monitoring using the Norwegian produced ECG247 sensor will be performed for 5-7 days. Single lead ECG data is sent to a cloudbased server intermittently. The system stores information of ECG quality and is evaluated by trained algorithms which classify arrhythmias based on current criteria. All ECG recordings will be reviewed by a group of trained and experienced study nurses and physicians. In the event of clinically relevant arrhythmias, participants will be contacted as soon as possible and receive advice on follow-up with their general practitioner. Anticoagulation therapy and other treatments will be recommended if indicated according to current guidelines.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1902', 'city': 'Tromsø', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Agnethe Eltoft, MD, PhD', 'role': 'CONTACT', 'email': 'agnethe.eltoft@uit.no', 'phone': '004797193417'}], 'facility': 'Uit The Arctic University of Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'city': 'Tromsø', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Agnethe Eltoft, MD, PhD', 'role': 'CONTACT', 'email': 'agnethe.eltoft@unn.no'}], 'facility': 'University Hospital of North Norway Health Trust', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'centralContacts': [{'name': 'Agnethe Eltoft, MD, PhD', 'role': 'CONTACT', 'email': 'agnethe.eltoft@unn.no', 'phone': '+4797193417'}, {'name': 'Emelia Gjesvik', 'role': 'CONTACT', 'email': 'emelia.e.gjesvik@uit.no'}], 'overallOfficials': [{'name': 'Tor Ingenbrigtsen', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of North Norway'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'collaborators': [{'name': 'UiT The Arctic University of Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}