Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-26 @ 10:35 AM
Study NCT ID:
NCT01509495
Status:
TERMINATED
Last Update Posted:
2014-07-04
First Post:
2011-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impedance Measurements in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'whyStopped': 'Enrollment rate too low; rate much under estimation of sponsor and investigators', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-03', 'studyFirstSubmitDate': '2011-12-07', 'studyFirstSubmitQcDate': '2012-01-10', 'lastUpdatePostDateStruct': {'date': '2014-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement', 'timeFrame': 'every 4 hours up to 48 hours'}], 'secondaryOutcomes': [{'measure': 'Accuracy of Respiratory rate determined by impedance measurements', 'timeFrame': 'every 4 hours up to 48 hours'}, {'measure': 'Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional)', 'timeFrame': 'every 4 hours up to 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'HF'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure impedance during inpatient treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients admitted to hospital for symptoms of congestive heart failure\n* patients older than 18 years\n* patients willing and able to give informed consent\n\nExclusion Criteria:\n\n* patients who will require adrenergic or positive inotropic medications\n* patients enrolled in a concurrent study that may confound the results of this study\n* patients unable or unwilling to participate in study procedures\n* patients who are pregnant\n* patients who are mentally handicapped or legal incompetent\n* patients who are dependent on investigator or sponsor'}, 'identificationModule': {'nctId': 'NCT01509495', 'acronym': 'SIM-HF', 'briefTitle': 'Impedance Measurements in Heart Failure Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic BRC'}, 'officialTitle': 'Impedance Measurements in Heart Failure Patients', 'orgStudyIdInfo': {'id': 'RAE00564'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Akern BIA101 and Custom Device', 'type': 'DEVICE', 'description': 'Impedance Measurement every 4 hours'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15030', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Nemocnice Na Homolce', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '97080', 'city': 'Würzburg', 'state': 'Franken', 'country': 'Germany', 'facility': 'Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '83348', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'NUSCH', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], 'overallOfficials': [{'name': 'Sebastian KG Maier, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum St. Elisabeth Straubing, Med. Klinik II, St.-Elisabeth-Str. 23, 94315 Straubing, Germany'}, {'name': 'Eva Goncalvesova, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NUSCH, Cardiac Surgery, Pod Krasnou horkou 1, 83348 Bratislava, Slovakia'}, {'name': 'Petr Neuzil, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nemocnice Na Homolce, Cardiology, Roentgenova 2/37, 150 30 Praha 5, Czechia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic BRC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}