Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-30 @ 9:10 AM
Study NCT ID:
NCT01429857
Status:
COMPLETED
Last Update Posted:
2013-06-14
First Post:
2011-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-13', 'studyFirstSubmitDate': '2011-02-01', 'studyFirstSubmitQcDate': '2011-09-05', 'lastUpdatePostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to cardiovascular death or hospitalization', 'timeFrame': '6 Months Follow-Up'}], 'secondaryOutcomes': [{'measure': 'Time to all cause death or hospitalization', 'timeFrame': '6 Months Follow-Up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Troponin concentration in heart failure'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '25408112', 'type': 'DERIVED', 'citation': 'Poss J, Ukena C, Kindermann I, Ehrlich P, Fuernau G, Ewen S, Mahfoud F, Kriechbaum S, Bohm M, Link A. Angiopoietin-2 and outcome in patients with acute decompensated heart failure. Clin Res Cardiol. 2015 May;104(5):380-7. doi: 10.1007/s00392-014-0787-y. Epub 2014 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the prognostic value of admission high-sensitivity troponin in patients with acute decompensated heart failure.', 'detailedDescription': 'Patients admitted for acute decompensated heart failure are included in the study. After gaining informed consent, concentrations of high-sensitivity troponin on admission and on discharge are assessed. 6 months after discharged, the incidence of clinical endpoint (mortality of all cause and of cardiovascular cause, hospitalization) is assessed by telephone contact to the patient and/or the physician. The aim of the study is to investigate the prognostic value of high-sensitivity troponin concentration for predicting death and re-hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospital admission for acute cardiac decompensation\n* Systolic and / or diastolic heart failure\n\nExclusion Criteria:\n\n* Myocardial infarction in the last 4 weeks\n* Serum creatinine \\>2.5 mg/dl\n* Pulmonary embolism'}, 'identificationModule': {'nctId': 'NCT01429857', 'briefTitle': 'Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Saarland'}, 'officialTitle': 'Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': 'Hom-AHF-Troponin'}}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Innere Medizin III - Kardiologie, Angiologie und Internistische Intensivtherapie', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Christian Ukena', 'investigatorFullName': 'Christian Ukena', 'investigatorAffiliation': 'University Hospital, Saarland'}}}}