Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 6:37 PM
Study NCT ID:
NCT00318357
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2006-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CARE-HF Long Term Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': 'Telephone: 0044 1482 624084', 'title': 'John Cleland, Professor', 'organization': 'The University of Hull; Department of Cardiology; United Kingdom'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '8-year. The patients that were still alive after closure of the CARE-HF study (2005,NCT00170300), that were willing to participate in the CARE-HF LTFU study continued additional follow-up for 4 years, till end 2009. The reported mortality data is the combined mortality of the CARE-HF and the CARE-HF LTFU study. Study start CARE-HF 2000.During the CARE-HFF LTFU study only mortality data was collected, no other adverse event data was collected..', 'description': 'No Serious Adverse Events or Adverse events were collected during the CARE-HF LTFU study.\n\nAll-Cause Mortality was monitored/assessed. Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Cardiac REsynchronization Therapy', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 173, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 39, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Upgrade to Cardiac Resynchronization Therapy', 'description': 'CARE-HF LTFU study continued to follow up the original CARE-HF control group patients. With a recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 136, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 32, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Resynchronization Therapy', 'description': 'In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment.\n\nMedtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine.'}, {'id': 'OG001', 'title': 'Upgrade to Cardiac Resynchronization Therapy', 'description': 'In the CARE-HF study patients treated with standard medical treatment. In the CARE-HF Long Term Follow-up part, almost all patients received CRT therapy on top of Optimal Medical Treatment. The CARE-HF LTFU study aims to further investigate mortality.\n\nCARE-HF LTFU study continued to follow up the original CARE-HF control group patients. With a recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}, {'value': '64.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Mortality is compared between the arms of the CARE-HF study, using Cox proportional hazards regression. Data from the original CARE-HF trial and the CARE-HF Long Term Follow-up trial were combined for the analysis.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '8-year', 'description': 'Long-term mortality with cardiac resynchronization therapy in the Cardiac Resynchronization-Heart Failure (CARE-HF) trial.\n\nThe patients that were still alive after closure of the CARE-HF study (2005,NCT00170300), that were willing to participate in the CARE-HF LTFU study continued additional follow-up for 4 years, till end 2009. The reported mortality data is the combined mortality of the CARE-HF and the CARE-HF LTFU study. Study start CARE-HF 2000.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from the CARE-HF and CARE-HF Long-Term Follow-Up studies were combined for analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cardiac Resynchromization Therapy', 'description': 'In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment.\n\nMedtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine.'}, {'id': 'FG001', 'title': 'Cardiac Resynchromization Therapy (Control Pts in CARE-HF', 'description': 'In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment. After release\n\nMedtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '32'}]}]}], 'recruitmentDetails': 'Patient alive from original CARE-HF study consented for long term follow-up'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cardiac Resynchromization Therapy (Control Pts in CARE-HF)', 'description': 'In the CARE-HF study patients treated with standard medical treatment. In the CARE-HF Long Term Follow-up part, almost all patients received CRT therapy on top of Optimal Medical Treatment. The CARE-HF LTFU study aims to further investigate mortality.\n\nCARE-HF LTFU study continued to follow up the original CARE-HF control group patients. With a recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.'}, {'id': 'BG001', 'title': 'Cardiac Resynchromization Therapy', 'description': 'In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment.\n\nMedtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '56', 'upperLimit': '70'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '59', 'upperLimit': '71'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '56', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'NYHA functional class III', 'classes': [{'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'New York Heart Association (NYHA) functional classification. It places patients in one of four catagories based on how much they are limited during physical activity. NYHA class III patient symptoms: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.', 'unitOfMeasure': 'participants'}, {'title': 'QRS', 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000', 'lowerLimit': '152', 'upperLimit': '180'}, {'value': '160', 'groupId': 'BG001', 'lowerLimit': '152', 'upperLimit': '180'}, {'value': '160', 'groupId': 'BG002', 'lowerLimit': '152', 'upperLimit': '180'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ms', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'No biospecimens are retained'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 309}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2006-04-25', 'resultsFirstSubmitDate': '2017-11-13', 'studyFirstSubmitQcDate': '2006-04-25', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-01', 'studyFirstPostDateStruct': {'date': '2006-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All Cause Mortality', 'timeFrame': '8-year', 'description': 'Long-term mortality with cardiac resynchronization therapy in the Cardiac Resynchronization-Heart Failure (CARE-HF) trial.\n\nThe patients that were still alive after closure of the CARE-HF study (2005,NCT00170300), that were willing to participate in the CARE-HF LTFU study continued additional follow-up for 4 years, till end 2009. The reported mortality data is the combined mortality of the CARE-HF and the CARE-HF LTFU study. Study start CARE-HF 2000.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac Resynchronization therapy (CRT)', 'All-cause mortality', 'Long-term follow-up'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '11511435', 'type': 'BACKGROUND', 'citation': 'Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Klein W, Tavazzi L; CARE-HF study Steering Committee and Investigators. The CARE-HF study (CArdiac REsynchronisation in Heart Failure study): rationale, design and end-points. Eur J Heart Fail. 2001 Aug;3(4):481-9. doi: 10.1016/s1388-9842(01)00176-3.'}, {'pmid': '15753115', 'type': 'RESULT', 'citation': 'Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.'}, {'pmid': '22552183', 'type': 'RESULT', 'citation': 'Cleland JG, Freemantle N, Erdmann E, Gras D, Kappenberger L, Tavazzi L, Daubert JC. Long-term mortality with cardiac resynchronization therapy in the Cardiac Resynchronization-Heart Failure (CARE-HF) trial. Eur J Heart Fail. 2012 Jun;14(6):628-34. doi: 10.1093/eurjhf/hfs055. Epub 2012 May 2.'}]}, 'descriptionModule': {'briefSummary': "The CARE-HF long-term follow-up trial evaluates the effects of cardiac resynchronization (CR) therapy on the mortality of patients from the CARE-HF program for an additional 4 year follow-up. Investigators are free to choose whatever available treatment they believe is in the patient's best interest.", 'detailedDescription': "The CARE-HF study enrolled 813 patients from 82 centers in 12 European countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK). All patients that were reported to be alive in May 2005 will be asked to participate.\n\nIn the CARE-HF LTFU program patients from the CARE-HF trial were asked to be enrolled for an additional 4 year follow-up. Investigators were free to choose whatever available treatment they believe is in the patient's best interest, however the outcome of the CARE-HF trial suggested that all patients should receive CRT therapy on top of Optimal Medical Treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic heart failure patients with NYHA class III-IV,with a LVEF of less than or equal to 35%, who are on optimal medical treatment, and documented evidence of ventricular dyssynchrony as evidenced by QRS or Echo prior enrollment in the CARE-HF main study.\n\nPatients who have participated in the CARE-HF program and were reported to be alive in May 2005 (study closure of the main study) are asked to participate in the CARE-HF LTFU study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have participated in the CARE-HF program and were reported to be alive in May 2005\n* Patients who signed a patient data release consent form\n\nExclusion Criteria:\n\n* Patients who have not participated in the CARE-HF program\n* Patients with exclusion criteria required by local legislation'}, 'identificationModule': {'nctId': 'NCT00318357', 'briefTitle': 'CARE-HF Long Term Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'CARE-HF LTFU: CArdiac REsynchronization in Heart Failure Long-term Follow-up', 'orgStudyIdInfo': {'id': 'CARE-HF Long-term follow-up'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRT in CARE-HF', 'description': 'In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment. In the CARE-HF Long Term Follow-up part, all patients received CRT therapy on top of Optimal Medical Treatment. The CARE-HF LTFU study aims to further investigate mortality.\n\nCARE-HF LTFU study continued ot follow up the original CARE-HF CRT group patients.', 'interventionNames': ['Device: Continuation of CRT']}, {'label': 'Control in CARE-HF', 'description': 'In the CARE-HF study patients treated with standard medical treatment. In the CARE-HF Long Term Follow-up part, almost all patients received CRT therapy on top of Optimal Medical Treatment. The CARE-HF LTFU study aims to further investigate mortality.\n\nCARE-HF LTFU study continued to follow up the original CARE-HF control group patients.', 'interventionNames': ['Device: Upgrade to CRT']}], 'interventions': [{'name': 'Continuation of CRT', 'type': 'DEVICE', 'otherNames': ['Resynchronisation system of the InSync® family'], 'description': 'Implantation of CRT device and medical treatment according normal hospital routine.', 'armGroupLabels': ['CRT in CARE-HF']}, {'name': 'Upgrade to CRT', 'type': 'DEVICE', 'otherNames': ['Resynchronisation system of the InSync® family'], 'description': 'Recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.', 'armGroupLabels': ['Control in CARE-HF']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU16 5JQ', 'city': 'Cottingham', 'state': 'Kingston-Upon-Hull', 'country': 'United Kingdom', 'facility': 'Hull Royal Infirmary - Academic Cardiology Unit', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}], 'overallOfficials': [{'name': 'John Cleland, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Hull; Department of Cardiology; United Kingdom'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}