Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 7:24 AM
Study NCT ID:
NCT00117234
Status:
COMPLETED
Last Update Posted:
2010-12-03
First Post:
2005-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Darbepoetin Alfa on Exercise Tolerance and Left Ventricular Structure in Subjects With Symptomatic Congestive Heart Failure (CHF) and Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2004-07'}, 'lastUpdateSubmitDate': '2010-12-02', 'studyFirstSubmitDate': '2005-06-30', 'studyFirstSubmitQcDate': '2005-06-30', 'lastUpdatePostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise tolerance, measured as peak VO(subscript)2'}], 'secondaryOutcomes': [{'measure': 'Exercise duration; *NYHA classification; *Patient-reported outcomes'}]}, 'conditionsModule': {'keywords': ['chronic heart failure', 'congestive heart failure', 'low hemoglobin', 'anemia', 'CHF', 'Symptomatic Congestive Heart Failure (CHF)'], 'conditions': ['Congestive Heart Failure', 'Anemia']}, 'referencesModule': {'references': [{'pmid': '17306703', 'type': 'DERIVED', 'citation': 'Ponikowski P, Anker SD, Szachniewicz J, Okonko D, Ledwidge M, Zymlinski R, Ryan E, Wasserman SM, Baker N, Rosser D, Rosen SD, Poole-Wilson PA, Banasiak W, Coats AJ, McDonald K. Effect of darbepoetin alfa on exercise tolerance in anemic patients with symptomatic chronic heart failure: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2007 Feb 20;49(7):753-62. doi: 10.1016/j.jacc.2006.11.024. Epub 2007 Feb 5.'}], 'seeAlsoLinks': [{'url': 'http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_33_NESP_20020126.pdf', 'label': 'To access clinical trial results information click on this link'}, {'url': 'http://www.aranesp.com/', 'label': 'FDA-approved Drug Labeling'}, {'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the effect of treatment with darbepoetin alfa on peak oxygen consumption (peak VO2) in subjects with symptomatic CHF and anemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Peak VO2 less than or equal to 16 ml/kg/min - Hemoglobin concentration between 9.0 and 12.0 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Unable to do cardiopulmonary exercise testing - Major organ transplant (e.g., lung, liver, heart) or renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion'}, 'identificationModule': {'nctId': 'NCT00117234', 'briefTitle': 'Impact of Darbepoetin Alfa on Exercise Tolerance and Left Ventricular Structure in Subjects With Symptomatic Congestive Heart Failure (CHF) and Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Study to Assess the Impact of Subcutaneous (SC) Darbepoetin Alfa Treatment on Exercise Tolerance and Left Ventricular Structure in Subjects With Symptomatic Congestive Heart Failure (CHF) and Anemia', 'orgStudyIdInfo': {'id': '20020126'}}, 'armsInterventionsModule': {'interventions': [{'name': 'darbepoetin alfa', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}