Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00922402
Status:
WITHDRAWN
Last Update Posted:
2025-07-03
First Post:
2009-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heart & Diabetes - Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2009-06-16', 'studyFirstSubmitQcDate': '2009-06-16', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average time to glycemic target (90-130 mg/dL)', 'timeFrame': 'Within two days after enrollment'}], 'secondaryOutcomes': [{'measure': 'Number of patient-days without deviations from the protocol', 'timeFrame': 'Within two days after enrollment'}, {'measure': 'Average glycemia in the first 6 hours', 'timeFrame': 'Within six hours after enrollment'}, {'measure': 'Slope of decremental curve of glycemia in the first 6 hours', 'timeFrame': 'Within six hours after enrollment'}, {'measure': 'Median number of glycemia controls/patient in the first 12 hours', 'timeFrame': 'Within twelve hours after enrollment'}, {'measure': 'Percentage of patients in glycemic range during the first 6 hours of infusion', 'timeFrame': 'Within six hours after enrollment'}, {'measure': 'Number of hypoglycemia episodes in the first 5 days', 'timeFrame': 'Within five days after enrollment'}, {'measure': 'Number of medical interventions and/or therapy variations based on blood glucose monitoring (finger-sticks) and/or suggested by interstitial continuous glucose monitoring glucose monitoring in the first 5 days', 'timeFrame': 'Within five days after enrollment'}, {'measure': 'HbA1c at 3 months and variation with respect to baseline', 'timeFrame': 'Within three months after enrollment'}, {'measure': 'Number of hypoglycemia episodes in the follow-up', 'timeFrame': 'Within three months after enrollment'}, {'measure': 'Evaluation of the number of finger-stick measurement and CGM readings', 'timeFrame': 'Within five days after enrollment'}, {'measure': 'Evaluation of the correlation between finger-stick measurement and CGM readings', 'timeFrame': 'Within five days after enrollement'}, {'measure': 'Number of times that therapy was changed after finger-stick confirmation when CGM values or alarms were indicating a therapy adjustment needs to be made', 'timeFrame': 'Within five days after enrollment'}, {'measure': 'Number of times that finger-stick overruled CGM readings or alarms not to do any therapy adjustment', 'timeFrame': 'WIthin five days after enrollment'}, {'measure': 'Evaluation of healthcare resource consumption', 'timeFrame': 'Within three months after enrollment'}, {'measure': 'Evaluation of organizational impact', 'timeFrame': 'Within three months after enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute', 'heart failure', 'hyperglycemia', 'Acute heart failure with high levels of glycemia'], 'conditions': ['Acute Heart Failure']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to validate an intensive protocol of insulin infusion and subsequent subcutaneous insulin administration with the support of continuous glucose monitoring, in addition to reference finger-stick values.', 'detailedDescription': 'Heart failure is a common disease (prevalence worldwide: 22 million; incidence worldwide: 2 million; prevalence in Italy: 750.000; incidence in Italy: 170.000), affecting 1-2% of overall population and accounting for a significant proportion of healthcare costs. Recurrent hospital admissions represent the majority of the disease-related cost. About 15-25% of patients with HF are diabetics: the presence of diabetes significantly worsens prognosis in patients with heart failure and increases the risk of death by 30% compared to subject without diabetes.\n\nThe intensive control of glycemia during acute heart failure is an objective of primary importance, which can be obtained only with a proper strategy of patient management and with a considerable organizational effort. In a shared protocol aimed at a tight control of glycemia, the use of Continuous Glucose Monitoring (CGM) is expected to allow an easier management of the patient and a more accurate implementation of the protocol.\n\nThe main purpose of this study is to validate an intensive protocol of insulin infusion and subsequent subcutaneous insulin administration with the support of continuous glucose monitoring, in addition to reference finger-stick values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (all of the following inclusion criteria must be met for the patient to be enrolled in the study):\n\n* acute heart failure, defined according to current ESC Guidelines\n* HbA1c \\> 7.5% at admission in Cardiology Unit\n* glycemia \\> 180 mg/dL at admission in Cardiology Unit\n* the patients signed the Informed Consent\n\nExclusion Criteria (if any of the following criteria are met, patients cannot be enrolled in the study):\n\n* heart failure in acute infarction or cardiogenic shock\n* creatinemia \\> 3.5 mg/dL at admission or in hemodialytic therapy\n* cirrhosis\n* acute infective pathology\n* cardiac revascularization during the hospitalization or in the preceding 3 months\n* life expectance \\< 12 months\n* age \\< 18 years\n* pregnant women\n* informed consent not signed\n* subject included in other protocols'}, 'identificationModule': {'nctId': 'NCT00922402', 'briefTitle': 'Heart & Diabetes - Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Heart & Diabetes - Feasibility Study', 'orgStudyIdInfo': {'id': 'Heart & Diabetes'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'All patients will be submitted to a shared intensive protocol of insulin infusion supported by continuous glucose monitoring', 'interventionNames': ['Procedure: Intensive insulin infusion']}], 'interventions': [{'name': 'Intensive insulin infusion', 'type': 'PROCEDURE', 'description': 'The intensive control of glycemia is obtained with a shared in-hospital insulin infusion protocol, supported by the use of a continuous glucose monitoring system (Medtronic Guardian REAL Time). Any sudden variation of glycemia levels and/or alarms, as indicated by the device, has to be confirmed with a finger-stick before any therapy modification.\n\nIn-hospital management is subdivided in a 2-day intensive and a 3-day post-intensive phase.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Catania', 'country': 'Italy', 'facility': 'Garibaldi Nesima Hospital', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'Policlinico S. Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Riccardo Vigneri, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Garibaldi-Nesima Hospital - Catania - Italy'}, {'name': 'Maddalena Lettino, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Policlinico S. Matteo - Pavia - Italy'}, {'name': 'Michele Gulizia, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Garibaldi-Nesima Hospital - Catania - Italy'}, {'name': 'Luigi Magnani, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Policlinico S. Matteo - Pavia - Italy'}, {'name': 'Luigi Tavazzi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ospedale Villa Maria Cecilia - Gruppo Villa Maria - Cotignola (Ravenna) - Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}