Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-06 @ 9:23 PM
Study NCT ID:
NCT01932294
Status:
COMPLETED
Last Update Posted:
2018-12-06
First Post:
2013-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D054143', 'term': 'Heart Failure, Systolic'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rongbingxie@uabmc.edu', 'phone': '205-975-3624', 'title': 'RongBing Xie', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'After the baseline visit and up to 24 months', 'eventGroups': [{'id': 'EG000', 'title': 'MedaMACS Participants', 'description': 'All participants who have met the inclusion criteria.', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 12, 'seriousNumAtRisk': 171, 'deathsNumAffected': 43, 'seriousNumAffected': 93}], 'otherEvents': [{'term': 'All-location Infection', 'notes': 'All-location Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Rehospitalization', 'notes': 'All-cause Rehospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 273, 'numAffected': 93}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IV Inotropes Dependent at 6 months', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Heart Failure Participants Deceased at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MedaMACS Participants', 'description': 'All participants who have met the inclusion criteria. By the end of the follow-up, 43 out of 171 patients died.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 month intervals after the baseline visit up to 24 months', 'description': 'Death after the baseline visit up to 24 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'By the end of the follow-up, 43 patients had deceased.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Known Ventricular Assist Device (VAD) Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MedaMACS Participants', 'description': 'All participants who have met the inclusion criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 month intervals after the baseline visit up to 24 months', 'description': 'Known VAD implantation after the baseline visit up to 24 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with known endpoints.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Known Heart Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MedaMACS Participants', 'description': 'All participants who have met the inclusion criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 month intervals after the baseline visit up to 24 months', 'description': 'Heart transplantation after the baseline visit up to 24 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with known endpoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MedaMACS Participants', 'description': 'All participants who have met the inclusion criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'VAD Implantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Heart Transplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Transferred to other hospitals', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MedaMACS Participants', 'description': 'All participants who have met the inclusion criteria.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '117', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant missed this variable'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.03', 'spread': '10.95', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '113', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One participant missing a value for the variable'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '160', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '119', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-11-16', 'size': 1476458, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-11-08T10:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-08', 'studyFirstSubmitDate': '2013-04-12', 'resultsFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2013-08-27', 'lastUpdatePostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-08', 'studyFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Heart Failure Participants Deceased at 24 Months', 'timeFrame': '6 month intervals after the baseline visit up to 24 months', 'description': 'Death after the baseline visit up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Known Ventricular Assist Device (VAD) Implantation', 'timeFrame': '6 month intervals after the baseline visit up to 24 months', 'description': 'Known VAD implantation after the baseline visit up to 24 months'}, {'measure': 'Number of Participants With Known Heart Transplantation', 'timeFrame': '6 month intervals after the baseline visit up to 24 months', 'description': 'Heart transplantation after the baseline visit up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Advanced Heart Failure', 'Refractory Heart Failure', 'Mechanical Circulatory Support Device', 'Ventricular Assist Device', 'Medamacs'], 'conditions': ['Heart Failure', 'Systolic Heart Failure']}, 'referencesModule': {'references': [{'pmid': '23352390', 'type': 'BACKGROUND', 'citation': 'Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Baldwin JT, Young JB. Fifth INTERMACS annual report: risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant. 2013 Feb;32(2):141-56. doi: 10.1016/j.healun.2012.12.004.'}], 'seeAlsoLinks': [{'url': 'http://www.intermacs.org', 'label': 'Click here for more information about this study: MedaMACS'}]}, 'descriptionModule': {'briefSummary': 'Medamacs is a prospective, observational study of ambulatory patients with advanced heart failure. The study enrolls patients who have not yet received a Left Ventricular Assist Device (LVAD) but who receive their care at a hospital with a Joint Commission certified mechanical circulatory support program.\n\nMedamacs is funded through the Interagency for Mechanically Assisted Circulatory Support (INTERMACS) NHLBI Contract.', 'detailedDescription': "Participants between 18 and 80 years old with low ejection fraction history and hospitalization for heart failure within the past year will be screened for the study. All subjects who have been admitted to the heart failure service will be screened and recruited, either as an inpatient or during their first outpatient follow-up appointment by the investigator and research staff caring for patients in the advanced heart failure program.\n\nEligibility for enrollment will be based only upon information that is clinically available at the time of screening. The history of prior hospitalizations will be available from clinical records.\n\nRoutine evaluation and triage of ambulatory patients with advanced heart disease includes echocardiography and functional assessment with peak oxygen consumption and frequently 6 minute walk distance. The elements of information required for estimation of the Seattle Heart Failure Risk score will be gleaned from laboratory data, or imputed as described in the Seattle score literature. The research coordinator will enter this data onto a currently available website for calculation of the Seattle score.\n\nEligibility will be determined by the inclusion and exclusion criteria and the study research team will approach individual subjects who are potential candidates for participation once the subject's primary physician has given permission to approach. Only persons with a scientific or ethical reason will be excluded. Incarcerated prisoners have been excluded by this protocol.\n\nParticipants will be followed every 6 months for 24 months after two baseline visits. The 6 month and 18 month follow ups consist of telephone interviews. Follow ups at 12 months and 24 months consists of routine clinical visits.\n\nApproximately 350 patients from 12 centers in the United States will be enrolled over a 12 month period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be screened for this study if they are between 18 and 80 years old with low ejection fraction history and hospitalization for heart failure within the past year. All subjects who have been admitted to the heart failure service will be screened and recruited for study participation, either as an inpatient or during their first outpatient follow-up appointment by the investigator and research staff caring for patients in the advanced heart failure program of the enrolling center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\nPatients with Advanced Heart Failure\n\n1. Age 18-80 years\n2. New York Heart Association class III-IV heart failure for 45 of the last 60 days\n3. Left ventricular ejection fraction ≤ 35%\n4. Heart failure diagnosis or typical symptoms for 12 months\n5. Use of evidence based oral medications (beta-blockers, ACE-inhibitors/ARBs, aldosterone antagonist) for at least 3 months prior to enrollment or documented medication contraindication or intolerance.\n6. Hospitalization for heart failure within the previous 12 months (other than for elective procedure)\n7. Informed consent given\n\nIn Addition, they must have at least one of the following:\n\nAn additional unplanned hospitalization during the previous 12 months for a total of at least 2 inpatient hospitalizations lasting \\>24 hours with heart failure as the primary or secondary diagnosis within the previous 12 months\n\nOR\n\n1. Peak oxygen uptake (VO2) \\<55% of age- and sex-predicted (using Wasserman equation) OR a peak VO2 ≤16 ml/kg/min for men and ≤14 ml/kg/min for women in a test with an RER \\>1.08 on cardiopulmonary exercise testing.\n2. 6-minute walk distance \\<300 meters without non-cardiac limitation.\n3. Serum BNP \\> 1000 (NT-proBNP \\> 4000 pg/ml) as outpatient or at hospital discharge.\n\nOR\n\nSeattle Heart Failure Model Score \\> 1.5.\n\nEXCLUSION CRITERIA:\n\n1. Age \\>80 years or \\<18 years\n2. Non-cardiac diagnosis anticipated to limit 2-year survival (≥30-50% mortality within 2 years from non-cardiac diagnosis)\n3. Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival\n4. QRS \\> 120msec and planned biventricular pacemaker implant or biventricular pacemaker implantation within past 90 days\n5. Current home intravenous inotrope therapy\n6. Chronic hemodialysis or peritoneal dialysis\n7. Scheduled for non-ventricular assist device cardiac surgery on current hospital admission\n8. Obvious anatomical or other major contra-indication to any cardiac surgery in the future (e.g. previous pneumonectomy, advanced connective tissue disease)\n9. Actively listed for heart transplant as UNOS Status 1 or 2\n10. History of cardiac amyloidosis\n11. Dominant lesion of at least moderate aortic or mitral stenosis or congenital structural heart defect.'}, 'identificationModule': {'nctId': 'NCT01932294', 'acronym': 'Medamacs', 'briefTitle': 'Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support', 'organization': {'class': 'NIH', 'fullName': 'National Heart, Lung, and Blood Institute (NHLBI)'}, 'officialTitle': 'Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support', 'orgStudyIdInfo': {'id': 'Medamacs'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MedaMACS participants', 'description': 'All participants who have met the inclusion criteria.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'James K Kirklin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INTERMACS Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) is not available. De-identified datasets may be available upon approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}