Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT04575857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-05
First Post:
2020-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012214', 'term': 'Rheumatic Heart Disease'}], 'ancestors': [{'id': 'D012213', 'term': 'Rheumatic Fever'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2040-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2040-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment rate', 'timeFrame': 'Measured at study enrollment', 'description': 'Defined as the proportion of approached eligible participants who consent to enroll in the study'}, {'measure': 'Medication adherence', 'timeFrame': 'Measured at month 1', 'description': 'The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken'}, {'measure': 'Medication adherence', 'timeFrame': 'Measured at months 6', 'description': 'The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken'}, {'measure': 'Medication adherence', 'timeFrame': 'Measured at months 12', 'description': 'The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken'}, {'measure': 'Medication adherence', 'timeFrame': 'Measured at months 18', 'description': 'The investigators will conduct a pill count to assess medication adherence and will report per participant as the percent of pills taken'}, {'measure': 'Retention rate', 'timeFrame': 'Measured at Month 18', 'description': 'Proportion of enrolled participants who come for followup evaluation and remain in the study until its completion'}, {'measure': 'Rate of progression of valvular disease', 'timeFrame': 'Change between baseline and Month 18', 'description': 'Compare month 18 echocardiogram with baseline echocardiogram'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatic Heart Disease', 'Valvular Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to address specific implementation questions necessary and sufficient to ensure the feasibility of the larger randomized trial examining the efficacy of statin medications in slowing rheumatic heart disease (RHD) valvular pathology progression. This feasibility study is intended to confirm the number of readily recruitable subjects, assess recruitment rate, and assess the rate of valve pathology via echocardiograms. These results are necessary and sufficient to facilitate the successful design of a large full scale randomized trial to determine whether statins improve outcomes in RHD. Successful treatment of RHD would fundamentally shift the RHD management paradigm world-wide, improve the lives of millions afflicted with RHD, and subsequently, decrease health care spending on RHD management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We have developed a comprehensive electronic database of RHD/RF patients in Nepal which will serve as the main data collection and participant recruitment mechanism.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years\n* History of RHD as evidenced by at least one echocardiographic examination\n* No history of cardiac surgery\n\nExclusion Criteria:\n\n* ≥ 75 or \\< 18 years old\n* Absence of RHD or RF history\n* Active liver disease\n* Impaired hepatic and renal function, including unexplained elevated levels of alanine transaminase greater than twice the upper limit of normal\n* History of previous statin intolerance or muscle disorders\n* Current pregnancy (by history or lab assessment of beta hCG) or plans for pregnancy in the next 18 months). Current lactation / breast feeding.\n* LDL \\<60'}, 'identificationModule': {'nctId': 'NCT04575857', 'briefTitle': 'Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression: A Feasibility Study For A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STUDY00008837'}, 'secondaryIdInfos': [{'id': '5R34HL143279', 'link': 'https://reporter.nih.gov/quickSearch/5R34HL143279', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Statin arm', 'description': 'To receive pill packet with atorvastatin (40mg/day) which will be taken nightly.', 'interventionNames': ['Drug: Atorvastatin']}, {'label': 'Placebo arm', 'description': 'To receive pill packet with placebo which will be taken nightly', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Statin'], 'description': 'Participants in the intervention arm will receive a pill packet with atorvastatin (40mg) x 18 months.', 'armGroupLabels': ['Statin arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants in the control arm will receive a pill packet with placebo x 18 months.', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kathmandu', 'country': 'Nepal', 'facility': 'Manmohan Memorial Medical College & Teaching Hospital.', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}], 'overallOfficials': [{'name': 'Nona Sotoodehnia, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Manmohan Cardiothoracic Vascular and Transplant Center', 'class': 'UNKNOWN'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Director, Cardiovascular Health Research Unit', 'investigatorFullName': 'Nona Sotoodehnia', 'investigatorAffiliation': 'University of Washington'}}}}