Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-01-02 @ 10:08 AM
Study NCT ID:
NCT01060293
Status:
TERMINATED
Last Update Posted:
2013-09-11
First Post:
2010-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dopamine in Acute Decompensated Heart Failure II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007008', 'term': 'Hypokalemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}, {'id': 'D004298', 'term': 'Dopamine'}], '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': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'whyStopped': 'Safety issues in the LDFD-group (higher heart rate with dopamine)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-10', 'studyFirstSubmitDate': '2010-02-01', 'studyFirstSubmitQcDate': '2010-02-01', 'lastUpdatePostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).', 'timeFrame': '1-year'}], 'secondaryOutcomes': [{'measure': '60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).', 'timeFrame': '60-day post discharge'}, {'measure': 'Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL)', 'timeFrame': 'Throughout hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Dopamine', 'Furosemide', 'Worsening Renal Function', 'Hypokalemia', 'Outcomes', 'Prognosis'], 'conditions': ['Acute Decompensated Heart Failure']}, 'referencesModule': {'references': [{'pmid': '24485633', 'type': 'DERIVED', 'citation': 'Triposkiadis FK, Butler J, Karayannis G, Starling RC, Filippatos G, Wolski K, Parissis J, Parisis C, Rovithis D, Koutrakis K, Skoularigis J, Antoniou CK, Chrysohoou C, Pitsavos C, Stefanadis C, Nastas J, Tsaknakis T, Mantziari L, Giannakoulas G, Karvounis H, Kalogeropoulos AP, Giamouzis G. Efficacy and safety of high dose versus low dose furosemide with or without dopamine infusion: the Dopamine in Acute Decompensated Heart Failure II (DAD-HF II) trial. Int J Cardiol. 2014 Mar 1;172(1):115-21. doi: 10.1016/j.ijcard.2013.12.276. Epub 2014 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effects of 1) high-dose furosemide, 2) low-dose furosemide, and 3) low-dose furosemide combined with low-dose dopamine on diuresis, clinical status, renal function, electrolyte balance, length of stay, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.', 'detailedDescription': 'The aim of this study is to compare the effects of:\n\n1. high-dose furosemide (HDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 20 mg/h for a total of 8 hours),\n2. low-dose furosemide (LDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide for a total of 8 hours), and\n3. low-dose furosemide combined with low-dose dopamine (LDFD, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide plus 5μg/kg/min dopamine for a total of 8 hours) on diuresis, perceived dyspnea, renal function, electrolyte balance, total length of stay, and 60-day post-discharge outcomes in patients hospitalized with ADHF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with New York Heart Association (NYHA) functional class IV heart failure according to the American Heart Association (AHA) classification, namely dyspnea on minimal exertion or rest dyspnea, orthopnea, and paroxysmal nocturnal dyspnea,\n* signs of congestion (third heart sound or pulmonary rales on physical examination),\n* pulmonary congestion on chest x-ray,\n* serum B-type natriuretic peptide levels \\> 400 pg/ml or NT-proBNP \\> 1500 pg/ml,\n* echocardiographic documentation of systolic or diastolic dysfunction,\n* age \\>18 years old,\n* on medical therapy with an ACE-inhibitor and/or a β-blocker,\n* experiencing an acute decompensation of known chronic HF,\n* baseline oxygen saturation \\<90% on admission arterial blood gas\n\nExclusion Criteria:\n\n* acute de novo HF;\n* severe renal failure (serum creatinine \\>200 μmol/L or GFR \\<30 ml/min/1.73m2)\n* admission systolic blood pressure \\<90 mm Hg;\n* severe valvular disease;\n* known adverse reactions to furosemide or dopamine;\n* HF secondary to congenital heart disease;\n* a scheduled procedure with a need for IV contrast dye;\n* a scheduled cardiac surgery within 6 months'}, 'identificationModule': {'nctId': 'NCT01060293', 'acronym': 'DAD-HF II', 'briefTitle': 'Dopamine in Acute Decompensated Heart Failure II', 'organization': {'class': 'OTHER', 'fullName': 'Larissa University Hospital'}, 'officialTitle': 'Comparison of High-dose Furosemide, Low-dose Furosemide, and the Combination of Low-dose Furosemide and Low-dose Dopamine in Patients With Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': '3975'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High-dose furosemide', 'description': 'High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours', 'interventionNames': ['Drug: High-dose furosemide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-dose furosemide', 'description': 'Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide', 'interventionNames': ['Drug: Low-dose furosemide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-dose furosemide combined with low-dose dopamine', 'description': 'Low-dose furosemide combined with low-dose dopamine (LDFD): continuous IV administration of 5 mg/h furosemide combined with 5 μg/kg/min dopamine for a total of 8 hours', 'interventionNames': ['Drug: Low-dose furosemide combined with low-dose dopamine']}], 'interventions': [{'name': 'High-dose furosemide', 'type': 'DRUG', 'description': 'High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours', 'armGroupLabels': ['High-dose furosemide']}, {'name': 'Low-dose furosemide', 'type': 'DRUG', 'description': 'Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide', 'armGroupLabels': ['Low-dose furosemide']}, {'name': 'Low-dose furosemide combined with low-dose dopamine', 'type': 'DRUG', 'description': 'Low-dose furosemide combined with low-dose dopamine (LDFD): continuous IV administration of 5 mg/h furosemide combined with 5 μg/kg/min dopamine for a total of 8 hours', 'armGroupLabels': ['Low-dose furosemide combined with low-dose dopamine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Division of Cardiology, Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'First Department of Cardiology, University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '411 10', 'city': 'Larissa', 'state': 'Larissa', 'country': 'Greece', 'facility': 'Department of Cardiology, Larissa University Hospital', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '382 21', 'city': 'Volos', 'state': 'Magnesia', 'country': 'Greece', 'facility': 'Department of Cardiology, Volos General Hospital', 'geoPoint': {'lat': 39.36923, 'lon': 22.94769}}, {'city': 'Thessaloniki', 'state': 'Thessaloniki', 'country': 'Greece', 'facility': 'AHEPA University Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Gregory Giamouzis, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Cardiology, Larissa University Hospital, Larissa, Greece'}, {'name': 'Filippos Triposkiadis, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Cardiology, Larissa University Hospital, Larissa, Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Larissa University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Cardiology', 'investigatorFullName': 'Gregory Giamouzis', 'investigatorAffiliation': 'Larissa University Hospital'}}}}