Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-02 @ 1:27 AM
Study NCT ID:
NCT00348504
Status:
COMPLETED
Last Update Posted:
2007-11-20
First Post:
2006-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077464', 'term': 'Simendan'}, {'id': 'D004280', 'term': 'Dobutamine'}], 'ancestors': [{'id': 'D006835', 'term': 'Hydrazones'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011724', 'term': 'Pyridazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-16', 'studyFirstSubmitDate': '2006-06-30', 'studyFirstSubmitQcDate': '2006-06-30', 'lastUpdatePostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality in the 180 days following randomization.'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality during the 31 days following randomization'}, {'measure': 'Mean change in plasma BNP concentration from baseline to 24 hours after the start of the study drug infusion'}, {'measure': 'Number of day alive and out of hospital (DAOH) during the 180 days following randomization'}, {'measure': "Patient's evaluation of change in dyspnea at 24 hours following randomization"}, {'measure': "Patient's evaluation of change in Global Assessment at 24 hours following randomization"}, {'measure': 'Cardiovascular mortality during the 180 days following randomization'}]}, 'conditionsModule': {'conditions': ['Acute Heart Failure']}, 'referencesModule': {'references': [{'pmid': '19539144', 'type': 'DERIVED', 'citation': 'Cohen-Solal A, Logeart D, Huang B, Cai D, Nieminen MS, Mebazaa A. Lowered B-type natriuretic peptide in response to levosimendan or dobutamine treatment is associated with improved survival in patients with severe acutely decompensated heart failure. J Am Coll Cardiol. 2009 Jun 23;53(25):2343-8. doi: 10.1016/j.jacc.2009.02.058.'}, {'pmid': '17473298', 'type': 'DERIVED', 'citation': 'Mebazaa A, Nieminen MS, Packer M, Cohen-Solal A, Kleber FX, Pocock SJ, Thakkar R, Padley RJ, Poder P, Kivikko M; SURVIVE Investigators. Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE Randomized Trial. JAMA. 2007 May 2;297(17):1883-91. doi: 10.1001/jama.297.17.1883.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to compare the efficacy of levosimendan and dobutamine on all-cause mortality in the 180 days following randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written, signed and dated informed consent\n* Male and female patients over 18 years of age. Females of childbearing potential must have a negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal \\[two years since last menstrual cycle\\], surgically sterilised or who have undergone a hysterectomy are considered not to be of childbearing potential\n* Hospitalised patients with acutely decompensated heart failure\n* Left ventricular ejection fraction less than or equal to 30 % as assessed using echocardiography, radionuclide ventriculography or contrast angiography within 12 months\n* Clinical need for intravenous inotropic support as evidenced by insufficient response to intravenous diuretics and/or vasodilators (nitroglycerin, nitroprusside) and at least one of the following at screening:\n\n * oliguria (mean urine output \\< 30 ml/h for at least 6 hours) and not a result of hypovolemia\n * dyspnoea at rest or mechanical ventilation for heart failure\n * haemodynamic impairment in those patients with Swan-Ganz catheter inserted (PCWP ≥ 18 mmHg and/or Cardiac Index ≤ 2.2 l/min/m2)\n\nExclusion Criteria:\n\n* Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy\n* Weight ≥ 160 kg\n* Cardiac surgery within 30 days before screening\n* Stroke within 3 months before screening\n* Systolic blood pressure persistently less than 85 mmHg at screening or at baseline\n* Heart rate persistently 130 bpm or greater at screening or at baseline\n* Serum potassium less than 3.5 mmol/l at screening\n* Administration of any inotropic agent (e.g. dobutamine, milrinone, amrinone, enoximone, epinephrine, norepinephrine) except digitalis or dopamine (with dose of less than or equal than 2 mg/kg/min) during the current hospitalisation\n* Hypersensitivity to levosimendan or dobutamine or any of their excipients\n* A history of Torsades de Pointes\n* Severe renal insufficiency (serum creatinine \\> 450 mmol/l \\[5.0 mg/dl\\]) or on dialysis\n* Significant hepatic impairment at discretion of the investigator\n* Acute bleeding\n* Severe anemia (haemoglobin \\< 8 g/dl) at screening\n* Septicaemia or septic shock\n* Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer)\n* Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study\n* Administration of levosimendan within 30 days prior to screening'}, 'identificationModule': {'nctId': 'NCT00348504', 'briefTitle': 'Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.', 'orgStudyIdInfo': {'id': '3001077'}}, 'armsInterventionsModule': {'interventions': [{'name': 'levosimendan', 'type': 'DRUG'}, {'name': 'dobutamine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60064', 'city': 'Abbott Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Global Medical Information - Abbott'}], 'overallOfficials': [{'name': 'Robert J Padley, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}]}}}