Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
Study NCT ID:
NCT00634400
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2008-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081643', 'term': 'candesartan'}, {'id': 'C077793', 'term': 'candesartan cilexetil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2008-03-07', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular mortality or hospitalisation due to congestive heart failure', 'timeFrame': '2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI', 'timeFrame': '2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Congestive Heart Failure', 'Atacand', 'Candesartan'], 'conditions': ['Congestive Heart Failure']}, 'referencesModule': {'references': [{'pmid': '37366061', 'type': 'DERIVED', 'citation': 'Kondo T, Dewan P, Anand IS, Desai AS, Packer M, Zile MR, Pfeffer MA, Solomon SD, Abraham WT, Shah SJ, Lam CSP, Jhund PS, McMurray JJV. Clinical Characteristics and Outcomes in Patients With Heart Failure: Are There Thresholds and Inflection Points in Left Ventricular Ejection Fraction and Thresholds Justifying a Clinical Classification? Circulation. 2023 Aug 29;148(9):732-749. doi: 10.1161/CIRCULATIONAHA.122.063642. Epub 2023 Jun 27.'}, {'pmid': '31982649', 'type': 'DERIVED', 'citation': 'Murray EJ, Claggett BL, Granger B, Solomon SD, Hernan MA. Adherence-adjustment in placebo-controlled randomized trials: An application to the candesartan in heart failure randomized trial. Contemp Clin Trials. 2020 Mar;90:105937. doi: 10.1016/j.cct.2020.105937. Epub 2020 Jan 23.'}, {'pmid': '29431256', 'type': 'DERIVED', 'citation': 'Lund LH, Claggett B, Liu J, Lam CS, Jhund PS, Rosano GM, Swedberg K, Yusuf S, Granger CB, Pfeffer MA, McMurray JJV, Solomon SD. Heart failure with mid-range ejection fraction in CHARM: characteristics, outcomes and effect of candesartan across the entire ejection fraction spectrum. Eur J Heart Fail. 2018 Aug;20(8):1230-1239. doi: 10.1002/ejhf.1149. Epub 2018 Feb 12.'}, {'pmid': '25326006', 'type': 'DERIVED', 'citation': 'Desai AS, Claggett B, Pfeffer MA, Bello N, Finn PV, Granger CB, McMurray JJ, Pocock S, Swedberg K, Yusuf S, Solomon SD. Influence of hospitalization for cardiovascular versus noncardiovascular reasons on subsequent mortality in patients with chronic heart failure across the spectrum of ejection fraction. Circ Heart Fail. 2014 Nov;7(6):895-902. doi: 10.1161/CIRCHEARTFAILURE.114.001567. Epub 2014 Oct 17.'}, {'pmid': '24874200', 'type': 'DERIVED', 'citation': 'Bello NA, Claggett B, Desai AS, McMurray JJ, Granger CB, Yusuf S, Swedberg K, Pfeffer MA, Solomon SD. Influence of previous heart failure hospitalization on cardiovascular events in patients with reduced and preserved ejection fraction. Circ Heart Fail. 2014 Jul;7(4):590-5. doi: 10.1161/CIRCHEARTFAILURE.113.001281. Epub 2014 May 29.'}, {'pmid': '22093207', 'type': 'DERIVED', 'citation': 'Ariti CA, Cleland JG, Pocock SJ, Pfeffer MA, Swedberg K, Granger CB, McMurray JJ, Michelson EL, Ostergren J, Yusuf S. Days alive and out of hospital and the patient journey in patients with heart failure: Insights from the candesartan in heart failure: assessment of reduction in mortality and morbidity (CHARM) program. Am Heart J. 2011 Nov;162(5):900-6. doi: 10.1016/j.ahj.2011.08.003. Epub 2011 Oct 7.'}, {'pmid': '19196892', 'type': 'DERIVED', 'citation': 'Preiss D, Zetterstrand S, McMurray JJ, Ostergren J, Michelson EL, Granger CB, Yusuf S, Swedberg K, Pfeffer MA, Gerstein HC, Sattar N; Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity Investigators. Predictors of development of diabetes in patients with chronic heart failure in the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM) program. Diabetes Care. 2009 May;32(5):915-20. doi: 10.2337/dc08-1709. Epub 2009 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 or above\n* Congestive Heart Failure with symptoms for more than 4 weeks before starting study\n* Provision of informed consent\n\nExclusion Criteria:\n\n* Current low blood pressure with symptoms\n* Liver disease considered significant by the study doctor\n* Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT00634400', 'briefTitle': 'Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Candesartan in Heart Fail. Assess. of Reduction in Mortality & Morbidity. Candesartan in Patients With Heart Failure Who Are ACE Inhibitor Intolerant and Have Depressed Left Ventricular Systolic Function', 'orgStudyIdInfo': {'id': 'SH-AHS-0003'}, 'secondaryIdInfos': [{'id': 'D2454C00003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Candesartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Candesartan', 'type': 'DRUG', 'otherNames': ['Atacand'], 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chris Granger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}