Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-30 @ 4:55 AM
Study NCT ID:
NCT01817803
Status:
WITHDRAWN
Last Update Posted:
2014-02-19
First Post:
2013-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Single-center, Open-label, Pilot Study to Compare the Effectiveness and Safety of Diuretics Add-On Strategy in Chronic Heart Failure Patients (DIOS 1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}, {'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'D008788', 'term': 'Metolazone'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D052999', 'term': 'Quinazolinones'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-17', 'studyFirstSubmitDate': '2013-03-20', 'studyFirstSubmitQcDate': '2013-03-22', 'lastUpdatePostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy and safety of diuretics add-on strategy', 'timeFrame': 'D+0, D+7, D+30, D+90', 'description': '1\\) body weight change, symptoms \\& signs change, systemic impedance change 2) serum \\& urine creatinine change, serum \\& urine electrolyte change, biomarkers change, clinical outcomes ( all-cause mortality, all-cause rehospitalization, start of renal replacement therapy)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart failure', 'diuretics', 'kidney', 'glomerular filtration rate'], 'conditions': ['Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': 'To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. dyspnea at rest or minimal activity\n2. tachypnea (respiratory rate \\> 20/min) or rales or pulmonary edema on chest X-ray\n3. who need diuretics add over 40mg of daily furosemide dose\n\nExclusion Criteria:\n\n1. Hospitalization for acute heart failure decompensation\n2. cardiogenic shock (Systolic Blood Pressure \\< 80mmHg)\n3. Need or plan for renal replacement therapy (dialysis, kidney transplant)\n4. serum creatine level \\> 2.5mg/dl\n5. serum potassium (K+) \\> 5.5mg/dl\n6. daily spironolactone dose \\> 50mg\n7. previous thiazide or metolazone user\n8. Age \\> 75 years old or poor compliance patients 9. allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics 10. life expectancy \\< 6 months (e.g. metastatic malignancy, liver cirrhosis) 11. pregnancy or women at age of childbearing potential'}, 'identificationModule': {'nctId': 'NCT01817803', 'briefTitle': 'A Prospective, Single-center, Open-label, Pilot Study to Compare the Effectiveness and Safety of Diuretics Add-On Strategy in Chronic Heart Failure Patients (DIOS 1)', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2013-0013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1) Add furosemide/no spironolactone', 'interventionNames': ['Drug: furosemide/no spironolactone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2) Add metolazone/no spironolactone', 'interventionNames': ['Drug: metolazone/no spironolactone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3) Add furosemide/spironolactone', 'interventionNames': ['Drug: furosemid/spironolactone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4) Add metolazone/spironolactone', 'interventionNames': ['Drug: metolazone/spironolactone']}], 'interventions': [{'name': 'furosemide/no spironolactone', 'type': 'DRUG', 'description': 'furosemide (doubling previous furosemide dose)', 'armGroupLabels': ['1) Add furosemide/no spironolactone']}, {'name': 'metolazone/no spironolactone', 'type': 'DRUG', 'description': 'metolazone (add 2.5mg qod)', 'armGroupLabels': ['2) Add metolazone/no spironolactone']}, {'name': 'furosemid/spironolactone', 'type': 'DRUG', 'description': 'furosemide (doubling previous furosemide dose)+spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)', 'armGroupLabels': ['3) Add furosemide/spironolactone']}, {'name': 'metolazone/spironolactone', 'type': 'DRUG', 'description': 'metolazone (add 2.5mg qod)+ spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)', 'armGroupLabels': ['4) Add metolazone/spironolactone']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}