Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-03-28 @ 1:36 PM
Study NCT ID:
NCT02052804
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2014-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-02', 'studyFirstSubmitDate': '2014-01-21', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of patients meeting new diagnostic criteria for HFpEF', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '26010610', 'type': 'DERIVED', 'citation': 'Zordoky BN, Sung MM, Ezekowitz J, Mandal R, Han B, Bjorndahl TC, Bouatra S, Anderson T, Oudit GY, Wishart DS, Dyck JR; Alberta HEART. Metabolomic fingerprint of heart failure with preserved ejection fraction. PLoS One. 2015 May 26;10(5):e0124844. doi: 10.1371/journal.pone.0124844. eCollection 2015.'}, {'pmid': '25063541', 'type': 'DERIVED', 'citation': 'Ezekowitz JA, Becher H, Belenkie I, Clark AM, Duff HJ, Friedrich MG, Haykowsky MJ, Howlett JG, Kassiri Z, Kaul P, Kim DH, Knudtson ML, Light PE, Lopaschuk GD, McAlister FA, Noga ML, Oudit GY, Paterson DI, Quan H, Schulz R, Thompson RB, Weeks SG, Anderson TJ, Dyck JR. The Alberta Heart Failure Etiology and Analysis Research Team (HEART) study. BMC Cardiovasc Disord. 2014 Jul 25;14:91. doi: 10.1186/1471-2261-14-91.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are: 1) to design new diagnostic criteria used to accurately define heart failure with preserved ejection fraction (HFpEF); 2) to better define the risk factors associated with HFpEF; 3) to elucidate the clinical, cellular and molecular mechanisms involved with the development and progression of HFpEF; 4) to design and test new therapeutic strategies for patients with HFpEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of Alberta, Canada with heart failure or at risk for developing heart failure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group 1 No clinically overt heart failure\n* Group 2 Known coronary artery disease\n* Group 3 Known heart failure with preserved ejection fraction\n* Group 4 Known heart failure with reduced ejection fraction\n* Group 5 Healthy age-matched controls\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Known malignancy with expected survival \\<1 year\n* Pregnant or recent pregnancy \\<6 months\n* Recent event (\\<2 weeks since Acute Coronary Syndrome, Heart failure or other admission\n* Severe mitral or aortic stenosis'}, 'identificationModule': {'nctId': 'NCT02052804', 'acronym': 'Alberta HEART', 'briefTitle': 'Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics', 'orgStudyIdInfo': {'id': 'AHFMRITG200801018'}}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2E1', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Jason Dyck, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, University of Alberta; Director, Heart Function Clinic- Mazankowski Alberta Heart Institute', 'investigatorFullName': 'Justin Ezekowitz', 'investigatorAffiliation': 'University of Alberta'}}}}