Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-27 @ 12:47 PM
Study NCT ID:
NCT00574756
Status:
TERMINATED
Last Update Posted:
2019-08-02
First Post:
2007-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054144', 'term': 'Heart Failure, Diastolic'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069458', 'term': 'Ranolazine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'no funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-31', 'studyFirstSubmitDate': '2007-12-14', 'studyFirstSubmitQcDate': '2007-12-14', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in E/Ea', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'changes in mitral inflow parameters (E, A, IVRT, DT)', 'timeFrame': '2 weeks'}, {'measure': 'Changes in tissue doppler parameters (Ea, Aa)', 'timeFrame': '2 weeks'}, {'measure': 'Changes in pulmonary venous inflow (S, D, a reversal)', 'timeFrame': '2 weeks'}]}, 'conditionsModule': {'conditions': ['Ranolazine', 'Diastolic Heart Failure', 'Tissue Doppler Ultrasound', 'Echocardiography']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of ranolazine, an FDA-approved medication for the treatment of angina, on heart function by using echocardiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate of severe diastolic dysfunction, E/Ea\\>12\n* Preserved systolic function\n* NYHA Class I-II\n\nExclusion Criteria:\n\n* QTc \\>450 msec at enrollment\n* Taking medications that prolong QT interval or are potent inhibitors of CYP3A\n* Significant coronary artery disease\n* Severe valvular disease\n* Hepatic disease\n* Severe kidney disease\n* Women of childbearing age\n* Prior serious ventricular arrhythmia'}, 'identificationModule': {'nctId': 'NCT00574756', 'briefTitle': 'Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction', 'orgStudyIdInfo': {'id': '070480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Active drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks', 'interventionNames': ['Drug: ranolazine']}, {'type': 'OTHER', 'label': '2', 'description': 'Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks', 'interventionNames': ['Drug: ranolazine']}], 'interventions': [{'name': 'ranolazine', 'type': 'DRUG', 'otherNames': ['Ranexa'], 'description': 'extended release 500 mg twice a day for two weeks', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Anthony DeMaria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}