Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:24 PM
Study NCT ID:
NCT01721967
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2012-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ranolazine for the Treatment of Chest Pain in HCM Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.wang@duke.edu', 'phone': '919-681-6197', 'title': 'Andrew Wang, MD', 'organization': 'Duke University Health System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ranolazine', 'description': 'Ranolazine, 500 mg for 60 days', 'otherNumAtRisk': 14, 'otherNumAffected': 2, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leg Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': 'Ranolazine, 500 mg for 60 days'}], 'classes': [{'categories': [{'measurements': [{'value': '462.8', 'spread': '27.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 Days', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Adverse Events Considered Probably or Possibly Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': 'Ranolazine, 500 mg for 60 days'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 Days', 'description': 'Number of events that are considered probably or possibly related to study drug.', 'unitOfMeasure': 'adverse event', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Drug Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': 'Ranolazine, 500 mg for 60 days'}], 'classes': [{'title': '1000 mg BID', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '500 mg BID', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 days', 'description': 'Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improvement in Number of Episodes of Angina Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': 'Ranolazine, 500 mg for 60 days'}], 'timeFrame': 'Baseline and 60 Days post treatment', 'description': 'Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).', 'reportingStatus': 'POSTED', 'populationDescription': 'episodes of angina per week was not collected'}, {'type': 'SECONDARY', 'title': 'Seattle Angina Questionnaire (SAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': 'Ranolazine, 500 mg for 60 days'}], 'classes': [{'title': 'Physical limitation', 'categories': [{'measurements': [{'value': '61.4', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Anginal stability', 'categories': [{'measurements': [{'value': '90.0', 'spread': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'Anginal frequency', 'categories': [{'measurements': [{'value': '86.0', 'spread': '12.7', 'groupId': 'OG000'}]}]}, {'title': 'Treatment satisfaction', 'categories': [{'measurements': [{'value': '90.6', 'spread': '11.5', 'groupId': 'OG000'}]}]}, {'title': 'Quality of life', 'categories': [{'measurements': [{'value': '70.8', 'spread': '11.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 Days post treatment', 'description': 'The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': 'Ranolazine, 500 mg for 60 days'}], 'classes': [{'title': 'Physical limitation', 'categories': [{'measurements': [{'value': '72', 'spread': '20.6', 'groupId': 'OG000'}]}]}, {'title': 'Symptom stability', 'categories': [{'measurements': [{'value': '72.7', 'spread': '26.1', 'groupId': 'OG000'}]}]}, {'title': 'Symptom frequency', 'categories': [{'measurements': [{'value': '72.2', 'spread': '20', 'groupId': 'OG000'}]}]}, {'title': 'Symptom burden', 'categories': [{'measurements': [{'value': '75', 'spread': '24.2', 'groupId': 'OG000'}]}]}, {'title': 'Total symptom score', 'categories': [{'measurements': [{'value': '73.6', 'spread': '21.3', 'groupId': 'OG000'}]}]}, {'title': 'Self-efficacy', 'categories': [{'measurements': [{'value': '85.2', 'spread': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Quality of life', 'categories': [{'measurements': [{'value': '65.2', 'spread': '25.8', 'groupId': 'OG000'}]}]}, {'title': 'Social limitation', 'categories': [{'measurements': [{'value': '66.1', 'spread': '31.2', 'groupId': 'OG000'}]}]}, {'title': 'Overall summary', 'categories': [{'measurements': [{'value': '69.8', 'spread': '23.5', 'groupId': 'OG000'}]}]}, {'title': 'Clinical summary', 'categories': [{'measurements': [{'value': '74', 'spread': '20.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days post treatement', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered \\> 10 points and \\>5 points, respectively, as previously established', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ranolazine', 'description': 'Ranolazine, 500 mg for 60 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ranolazine', 'description': 'Ranolazine, 500 mg for 60 days'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '9.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Seattle Angina Questionnaire', 'classes': [{'title': 'Physical limitation', 'categories': [{'measurements': [{'value': '49.6', 'spread': '18.7', 'groupId': 'BG000'}]}]}, {'title': 'Anginal stability', 'categories': [{'measurements': [{'value': '45.5', 'spread': '27.0', 'groupId': 'BG000'}]}]}, {'title': 'Anginal frequency', 'categories': [{'measurements': [{'value': '65.5', 'spread': '13.4', 'groupId': 'BG000'}]}]}, {'title': 'Treatment satisfaction', 'categories': [{'measurements': [{'value': '85.2', 'spread': '12.6', 'groupId': 'BG000'}]}]}, {'title': 'Quality of life', 'categories': [{'measurements': [{'value': '40.9', 'spread': '24.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The SAQ is a self-report instrument with 19 items that yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'classes': [{'title': 'Physical limitation', 'categories': [{'measurements': [{'value': '61.7', 'spread': '20.6', 'groupId': 'BG000'}]}]}, {'title': 'Symptom stability', 'categories': [{'measurements': [{'value': '43.2', 'spread': '16.2', 'groupId': 'BG000'}]}]}, {'title': 'Symptom frequency', 'categories': [{'measurements': [{'value': '56.4', 'spread': '20.6', 'groupId': 'BG000'}]}]}, {'title': 'Symptom burden', 'categories': [{'measurements': [{'value': '55.3', 'spread': '29.4', 'groupId': 'BG000'}]}]}, {'title': 'Total symptom score', 'categories': [{'measurements': [{'value': '55.9', 'spread': '24.2', 'groupId': 'BG000'}]}]}, {'title': 'Self-efficacy', 'categories': [{'measurements': [{'value': '78.4', 'spread': '21.7', 'groupId': 'BG000'}]}]}, {'title': 'Quality of life', 'categories': [{'measurements': [{'value': '39.4', 'spread': '26.6', 'groupId': 'BG000'}]}]}, {'title': 'Social limitation', 'categories': [{'measurements': [{'value': '46.0', 'spread': '31.5', 'groupId': 'BG000'}]}]}, {'title': 'Overall summary', 'categories': [{'measurements': [{'value': '51.2', 'spread': '22.3', 'groupId': 'BG000'}]}]}, {'title': 'Clinical summary', 'categories': [{'measurements': [{'value': '58.8', 'spread': '20.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Similarly, the Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire developed to provide a better description of health-related quality of life in patients with heart failure. It quantifies, in a disease-specific fashion, physical limitation, symptoms (frequency, severity and recent change over time), quality of life, social interference and self-efficacy. All categories of questions are scored from 0-100, with higher number indicating better health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2012-11-02', 'resultsFirstSubmitDate': '2016-11-04', 'studyFirstSubmitQcDate': '2012-11-02', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-21', 'studyFirstPostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QT Interval', 'timeFrame': '60 Days'}, {'measure': 'Number of Adverse Events Considered Probably or Possibly Related to Study Drug', 'timeFrame': '60 Days', 'description': 'Number of events that are considered probably or possibly related to study drug.'}, {'measure': 'Drug Tolerability', 'timeFrame': '60 days', 'description': 'Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose'}], 'secondaryOutcomes': [{'measure': 'Improvement in Number of Episodes of Angina Per Week', 'timeFrame': 'Baseline and 60 Days post treatment', 'description': 'Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).'}, {'measure': 'Seattle Angina Questionnaire (SAQ)', 'timeFrame': '60 Days post treatment', 'description': 'The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.'}, {'measure': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': '60 days post treatement', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered \\> 10 points and \\>5 points, respectively, as previously established'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chest pain', 'dyspnea'], 'conditions': ['Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for the treatment of angina in a novel patient population (adult patient population with hypertrophic cardiomyopathy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Left Ventricle wall thickness \\>/= 15mm in the absence of other condition causing hypertrophy\n* Baseline Angina/Shortness of Breath Frequency of \\> 2 episodes per week\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Severe stenotic valvular disease\n* Severe valvular regurgitation except mitral regurgitation due to systolic anterior motion\n* Significant (\\>60% stenosis) coronary artery disease\n* Acute coronary syndrome within 30 days\n* Severe heart failure defined as LV systolic dysfunction with Ejection Fraction \\<40% or NYHA class 4 symptoms\n* Severe renal impairment (glomerular filtration rate, \\<30 mL/min/1.73 m2)\n* Moderate-severe hepatic impairment (Child-Pugh classes B and C)\n* Hospitalization for cardiac reason within 3 months of enrollment\n* Anticipated changes to treatment of HCM within study period, including medications, device implantation, or septal reduction therapies\n* Concomitant use of ketoconazole, macrolide antibiotics, and HIV protease inhibitors\n* Active myocarditis, pericarditis, or restrictive cardiomyopathy\n* Non-cardiac terminal illness with expected survival less than 6 months\n* Women who are of childbearing potential\n* Inability to perform or adhere to study protocol'}, 'identificationModule': {'nctId': 'NCT01721967', 'acronym': 'RHYME', 'briefTitle': 'Ranolazine for the Treatment of Chest Pain in HCM Patients', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation', 'orgStudyIdInfo': {'id': 'Pro00039302'}, 'secondaryIdInfos': [{'id': '3938381', 'type': 'OTHER', 'domain': 'Duke University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranolazine', 'description': 'Ranolazine, 500 mg for 60 days', 'interventionNames': ['Drug: Ranolazine']}], 'interventions': [{'name': 'Ranolazine', 'type': 'DRUG', 'otherNames': ['Ranexa'], 'armGroupLabels': ['Ranolazine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}