Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-27 @ 1:10 AM
Study NCT ID:
NCT01113866
Status:
COMPLETED
Last Update Posted:
2010-05-04
First Post:
2010-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers for Prognosis of Ambulatory Chronic 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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-03', 'studyFirstSubmitDate': '2010-04-29', 'studyFirstSubmitQcDate': '2010-04-29', 'lastUpdatePostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Biomarkers representing distinct biological domains including neurohormonal, inflammatory, metabolic-nutritional, oxidative-nitrosative and myocardial injury, might alone or in combination provide prognostic information on mortality in heart failure patients with preserved or impaired systolic function.', 'detailedDescription': 'Upon enrollment in the study, Troponin I (cTn I), BNP, norepinephrine, plasma renin activity, aldosterone, high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), soluble receptor of interleukin 2 (sIL-2R), leptin, prealbumin, free malondialdehyde, 15-F2t-isoprostane and protein-bound nitrotyrosine were measured in stable ambulatory, non diabetic, elderly heart failure patients. Patients were followed up until death or study termination (31st January 2009).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'heart failure patients with preserved or impaired systolic function', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic congestive heart failure lasting at least six months\n* reduced exercise tolerance\n* impaired or preserved left ventricular ejection fraction\n* cardiomegaly\n\nExclusion Criteria:\n\n* acute infection\n* rheumatoid or other autoimmune diseases\n* primary cachectic states (cancer, thyroid disease, severe liver disease)\n* severe chronic lung disease\n* neuromuscular disorders\n* myocardial infarction within the previous 20 weeks\n* diabetes mellitus\n* chronic renal failure (serum creatinine level \\> 2.0 mg/dl, \\>177 micromol/L)'}, 'identificationModule': {'nctId': 'NCT01113866', 'briefTitle': 'Biomarkers for Prognosis of Ambulatory Chronic Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Parma'}, 'officialTitle': 'Circulating Biomarkers as Prognostic Indicators of Death in Ambulatory Heart Failure Patients', 'orgStudyIdInfo': {'id': 'CV-1997-2002_A0013-29943'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'heart failure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43126', 'city': 'Parma', 'country': 'Italy', 'facility': 'Università di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Aderville Cabassi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Parma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Parma', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Aderville Cabassi', 'oldOrganization': 'Hypertension and Cardiorenal Disease Center Dept Internal Medicine Nephrology and Health Sciences University of Parma'}}}}