Ignite Creation Date:
2025-12-24 @ 10:43 PM
Ignite Modification Date:
2025-12-29 @ 9:06 PM
Study NCT ID:
NCT01390935
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2011-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real World
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019983', 'term': 'Guideline Adherence'}, {'id': 'D000451', 'term': 'Mineralocorticoid Receptor Antagonists'}], 'ancestors': [{'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D062865', 'term': 'Diuretics, Potassium Sparing'}, {'id': 'D004232', 'term': 'Diuretics'}, {'id': 'D045283', 'term': 'Natriuretic Agents'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-28', 'studyFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2011-07-07', 'lastUpdatePostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean of modified Guideline Adherence Indicator(mGAI-3)', 'timeFrame': '1year', 'description': "Modified percentage based on each participant's condition"}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with each class drug prescribed', 'timeFrame': '1year', 'description': 'ARB, BB, ACE-I, aldosterone antagonist'}, {'measure': 'Percentage of participants with daily target dose reached', 'timeFrame': '1year', 'description': 'ARB, BB, ACE-I, aldosterone antagonist'}, {'measure': 'Percentage of all cause mortality', 'timeFrame': '1year', 'description': 'All cause mortality in 1-year after treatment of systolic heart failure'}, {'measure': 'Percentage of All cause hospitalization', 'timeFrame': '1year', 'description': 'All cause hospitalization in 1-year after treatment of systolic heart failure'}, {'measure': 'Mean of mortality or rehospitalization rate according to mGAI-3', 'timeFrame': '1year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['guideline adherence', 'systolic heart failure'], 'conditions': ['Heart Failure, Congestive']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to survey the guideline compliance of the cardiologists in the treatment of systolic heart failure in Korea', 'detailedDescription': 'Major improvement in the medical management of CHF has been achieved in the past decades.\n\nBut there is no doubt that prognosis of heart failure patients remains poor. The compliance to the standard treatment can be one of reasons. But very little data concerning this in Korea is available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'admission for systolic heart failure in general hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects admitted to hospital with systolic heart failure(LVEF under 45%) in 2009\n* Subjects, age 20 or/and above\n* Subjects admitted to hospital (emergency area, to internal medicine or to cardiology wards, CCU or intensive care) with dyspnea and verification of heart failure based on following criteria;\n* Symptoms typical of heart failure : breathlessness at rest or on exercise, fatigue, tiredness, ankle swelling and Signs typical of heart failure : tachycardia, tachypnoea, pulmonary rales, pleural effusion, raised jugular venous pressure, peripheral oedema, hepatomegaly\n* Objective evidence of a structural or functional abnormality of the heart at rest : cardiomegaly, third heard sound, cardiac murmurs, abnormality on the echocardiogram, raised natriuretic peptide concentration\n\nExclusion Criteria:\n\n* Subject who expired during hospitalization'}, 'identificationModule': {'nctId': 'NCT01390935', 'acronym': 'SUGAR', 'briefTitle': 'SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real World', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real WorldMulticenter, Retrospective Observation Study in Korea', 'orgStudyIdInfo': {'id': '114993'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'systolic heart failure', 'description': 'EF under 45%', 'interventionNames': ['Other: guideline adherence']}], 'interventions': [{'name': 'guideline adherence', 'type': 'OTHER', 'otherNames': ['ACEI', 'ARB', 'BB', 'aldosterone antagonist'], 'description': 'guideline adherence of physician', 'armGroupLabels': ['systolic heart failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}