Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-26 @ 4:42 AM
Study NCT ID:
NCT00937092
Status:
UNKNOWN
Last Update Posted:
2010-05-26
First Post:
2009-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-25', 'studyFirstSubmitDate': '2009-06-29', 'studyFirstSubmitQcDate': '2009-07-09', 'lastUpdatePostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', '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 days post discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Dopamine', 'Furosemide', 'Worsening Renal Function', 'Hypokalemia', 'Outcomes', 'Prognosis'], 'conditions': ['Acute Heart Failure']}, 'referencesModule': {'references': [{'pmid': '21111980', 'type': 'DERIVED', 'citation': 'Giamouzis G, Butler J, Starling RC, Karayannis G, Nastas J, Parisis C, Rovithis D, Economou D, Savvatis K, Kirlidis T, Tsaknakis T, Skoularigis J, Westermann D, Tschope C, Triposkiadis F. Impact of dopamine infusion on renal function in hospitalized heart failure patients: results of the Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial. J Card Fail. 2010 Dec;16(12):922-30. doi: 10.1016/j.cardfail.2010.07.246.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effects of high-dose furosemide versus low-dose furosemide combined with low-dose dopamine on diuresis, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.', 'detailedDescription': 'Worsening renal function (WRF) and hypokalemia related to diuretic use for acute decompensated heart failure (ADHF) are common and portend poor prognosis. Low dose dopamine infusion improves renal perfusion. Whether dopamine infusion improves diuresis and/or reduces renal complication in ADHF is not known. The aim of this study is to compare the effects of high-dose furosemide (HDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 20 mg/h for a total of 8 hours) vs. 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, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with ADHF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', '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* all candidate patients must be:\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* Having baseline oxygen saturation \\<90% on admission arterial blood gas\n\nExclusion Criteria:\n\n* the investigators will exclude patients with:\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': 'NCT00937092', 'acronym': 'DAD-HF', 'briefTitle': 'Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial', 'organization': {'class': 'OTHER', 'fullName': 'Larissa University Hospital'}, 'officialTitle': 'Comparison of High-dose Furosemide Versus the Combination of Low-dose Furosemide and Low-dose Dopamine in Patients With Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': 'LUH-DC-101-FT'}}, '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: Furosemide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low-dose dopamine + low-dose furosemide', '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 dopamine + low-dose furosemide']}], 'interventions': [{'name': 'Furosemide', 'type': 'DRUG', 'description': 'High-dose furosemide(HDF, furosemide 20 mg/h intravenously)', 'armGroupLabels': ['High-dose furosemide']}, {'name': 'low-dose dopamine + low-dose furosemide', 'type': 'DRUG', 'description': 'low-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5μg/kg/min intravenously)', 'armGroupLabels': ['low-dose dopamine + low-dose furosemide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '411 10', 'city': 'Larissa', 'state': 'Larissa', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Gregory Giamouzis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Filippos Triposkiadis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'John Skoularigis, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dimitrios Economou, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'George Karayannis, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dimitrios Rovithis, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Charalambos Parisis, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Cardiology, Larissa University Hospital', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '382 21', 'city': 'Volos', 'state': 'Magnesia', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Themistoklis Tsaknakis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'John Nastas, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Themistoklis Kyrlidis, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Cardiology, Volos General Hospital', 'geoPoint': {'lat': 39.36923, 'lon': 22.94769}}], 'centralContacts': [{'name': 'Filippos Triposkiadis, MD', 'role': 'CONTACT', 'email': 'ftriposkiadis@yahoo.com', 'phone': '+30 2410682821'}, {'name': 'Gregory Giamouzis, MD', 'role': 'CONTACT', 'email': 'ggiamou@emory.edu', 'phone': '+30 6937212670'}], 'overallOfficials': [{'name': 'Gregory Giamouzis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Larissa University Hospital'}, {'name': 'Filippos Triposkiadis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Larissa University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Larissa University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gregory Giamouzis, MD', 'oldOrganization': 'Department of Cardiology, Larissa University Hospital'}}}}