Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT06099158
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2023-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be blinded to treatment allocation. Active-arm participants will be unblinded at the time of first HeartLogic alert.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1428}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospitalizations for heart failure (recurrent events)', 'timeFrame': '42 months'}, {'measure': 'Hierarchical composite of all-cause mortality, total number of heart failure hospitalizations, and total number of all-cause hospitalizations', 'timeFrame': '42 months'}, {'measure': 'All-cause readmission within 30 days after hospitalization for heart failure', 'timeFrame': '42 months'}, {'measure': 'Hospitalization for any cardiovascular disease', 'timeFrame': '42 months'}, {'measure': 'Hospitalization for any cardio-respiratory disease', 'timeFrame': '42 months'}, {'measure': 'Hospitalization for atrial fibrillation', 'timeFrame': '42 months'}, {'measure': 'Atrial fibrillation burden', 'timeFrame': '42 months'}, {'measure': 'Hospitalization for cardiac arrest', 'timeFrame': '42 months'}, {'measure': 'Ventricular tachyarrhythmia leading to anti-tachycardia pacing and/or shock', 'timeFrame': '42 months'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '42 months'}, {'measure': 'Incident heart failure (among participants without heart failure at baseline)', 'timeFrame': '42 months'}, {'measure': 'Days alive and out of hospital', 'timeFrame': '42 months'}, {'measure': 'Length of hospital stay', 'timeFrame': '42 months'}, {'measure': 'Use of guideline-directed medical therapy for heart failure', 'timeFrame': '42 months'}, {'measure': 'HeartLogic alert rate', 'timeFrame': '42 months'}, {'measure': 'Average HeartLogic index', 'timeFrame': '42 months'}, {'measure': 'Median HeartLogic alert length', 'timeFrame': '42 months'}, {'measure': '% time in HeartLogic alert', 'timeFrame': '42 months'}, {'measure': 'Maximal observed HeartLogic index', 'timeFrame': '42 months'}, {'measure': 'Time from HeartLogic alert to clinical event', 'timeFrame': '42 months'}, {'measure': 'Individual HeartLogic sensor trends', 'timeFrame': '42 months'}], 'primaryOutcomes': [{'measure': 'Composite endpoint of hospitalization for heart failure or all-cause death (first event)', 'timeFrame': '42 months'}], 'secondaryOutcomes': [{'measure': 'Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)', 'timeFrame': '42 months'}, {'measure': 'Hospitalization for heart failure (first event)', 'timeFrame': '42 months'}, {'measure': 'All-cause hospitalization', 'timeFrame': '42 months'}, {'measure': 'All-cause mortality', 'timeFrame': '42 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pragmatic', 'Heart disease', 'ICD', 'CRT-D', 'Pacemaker', 'Registry', 'HeartLogic'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.', 'detailedDescription': 'The study is a pragmatic, registry-based, randomized controlled trial. Eligible patients in Denmark will be randomized 1:1 to either HeartLogic-guided management or usual care. During the trial, patients in the HeartLogic arm will be contacted by the study team in case of any HeartLogic alerts for evaluation and treatment decisions. There will be no mandatory in-person visits scheduled in the trial. HeartLogic alerts will be managed according to a prespecified management guide. Trial data besides device-related data will be retrieved from the Danish nationwide health registries including baseline information and endpoint data. The control group will receive usual HF care in the Danish health system without the involvement of the study team. The study will comply with the standards of the CONSORT statement and the principles of the Declaration of Helsinki.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization\n2. Age ≥18 years\n3. Compliant with remote monitoring and not listed in the LATITUDE™ remote monitoring system as "not monitored"\n\nExclusion Criteria:\n\nThere are no specific exclusion criteria for the trial.'}, 'identificationModule': {'nctId': 'NCT06099158', 'acronym': 'DANLOGIC-HF', 'briefTitle': 'Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Herlev and Gentofte Hospital'}, 'officialTitle': 'Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes', 'orgStudyIdInfo': {'id': 'DANLOGIC-HF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HeartLogic-guided management', 'description': 'HeartLogic alerts will be transmitted to the study team, which will subsequently contact the participant to assess any treatment needs. Treatment needs will be assessed according to current clinical practice guidelines.', 'interventionNames': ['Other: HeartLogic']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'The control group will receive usual HF care in the Danish health system.'}], 'interventions': [{'name': 'HeartLogic', 'type': 'OTHER', 'description': 'HeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts.', 'armGroupLabels': ['HeartLogic-guided management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'state': 'Capital Region', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Niklas Dyrby Johansen, MD', 'role': 'CONTACT', 'email': 'niklas.dyrby.johansen@regionh.dk', 'phone': '+4520204794'}, {'name': 'Marie Terese Barlebo Madsen, PhD', 'role': 'CONTACT', 'email': 'marie.terese.barlebo.madsen@regionh.dk', 'phone': '+4553377345'}, {'name': 'Tor Biering-Sørensen, MD, MSc, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'centralContacts': [{'name': 'Niklas Dyrby Johansen, MD', 'role': 'CONTACT', 'email': 'niklas.dyrby.johansen@regionh.dk', 'phone': '+4520204794'}, {'name': 'Marie Terese Barlebo Madsen, PhD', 'role': 'CONTACT', 'email': 'marie.terese.barlebo.madsen@regionh.dk', 'phone': '+4553377345'}], 'overallOfficials': [{'name': 'Tor Biering-Sørensen, MD, MSc, MPH, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tor Biering-Sørensen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, MSc, MPH, PhD, MP', 'investigatorFullName': 'Tor Biering-Sørensen', 'investigatorAffiliation': 'Herlev and Gentofte Hospital'}}}}