Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-13 @ 1:16 PM
Study NCT ID:
NCT00634712
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2008-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)
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': 734}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-06'}, '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': ', 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': 'Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Congestive Heart Failure', 'Atacand', 'Candesartan'], 'conditions': ['Congestive Heart Failure']}, 'referencesModule': {'references': [{'pmid': '40864017', 'type': 'DERIVED', 'citation': 'Ostrominski JW, Hojbjerg Lassen MC, Butt JH, Claggett BL, Anand IS, Desai AS, Jhund PS, Lam CSP, Pfeffer MA, Pitt B, Zannad F, Zile MR, Packer M, McMurray JJV, Solomon SD, Vaduganathan M. Adiposity-Related Anthropometrics and Clinical Outcomes in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Participant-Level Pooled Analysis of Randomized Clinical Trials. J Am Coll Cardiol. 2025 Nov 18;86(20):1760-1777. doi: 10.1016/j.jacc.2025.08.012. Epub 2025 Aug 27.'}, {'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': '36632831', 'type': 'DERIVED', 'citation': 'Curtain JP, Adamson C, Kondo T, Butt JH, Desai AS, Zannad F, Rouleau JL, Rohde LE, Kober L, Anand IS, van Veldhuisen DJ, Zile MR, Lefkowitz MP, Solomon SD, Packer M, Petrie MC, Jhund PS, McMurray JJV. Investigator-reported ventricular arrhythmias and mortality in heart failure with mildly reduced or preserved ejection fraction. Eur Heart J. 2023 Feb 21;44(8):668-677. doi: 10.1093/eurheartj/ehac801.'}, {'pmid': '33301080', 'type': 'DERIVED', 'citation': 'Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction. Clin Res Cardiol. 2021 Aug;110(8):1234-1248. doi: 10.1007/s00392-020-01786-8. Epub 2020 Dec 10.'}, {'pmid': '31370950', 'type': 'DERIVED', 'citation': 'Tromp J, Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Kober L, Swedberg K, Zile MR, Pitt B, Lam CSP, McMurray JJV. Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Aug 6;74(5):601-612. doi: 10.1016/j.jacc.2019.05.052.'}, {'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': '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 preserved left ventricular function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, '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': 'NCT00634712', 'briefTitle': 'Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity. Clinical Study of Candesartan in Patients With Heart Failure and Preserved Left Ventricular Systolic Function', 'orgStudyIdInfo': {'id': 'SH-AHS-0007'}, 'secondaryIdInfos': [{'id': 'D2454C00007'}]}, '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': 'Dr Salim Yusuf', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}