Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-01 @ 8:04 PM
Study NCT ID:
NCT01061450
Status:
COMPLETED
Last Update Posted:
2010-02-03
First Post:
2010-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simvastatin and Diastolic Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-02', 'studyFirstSubmitDate': '2010-02-02', 'studyFirstSubmitQcDate': '2010-02-02', 'lastUpdatePostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes in E/A ratio and e' wave velocity", 'timeFrame': '20 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in left atrium volume.', 'timeFrame': '20 weeks'}, {'measure': 'Changes in left ventricular mass.', 'timeFrame': '20 weeks'}, {'measure': 'Changes in e´/a´ waves ratio.', 'timeFrame': '20 weeks'}, {'measure': 'Changes in mitral deceleration time.', 'timeFrame': '20 weeks'}, {'measure': 'Changes in the ratio of mitral inflow velocity to annular relaxation velocity.', 'timeFrame': '20 weeks'}, {'measure': 'Changes in mitral annulus systolic velocity', 'timeFrame': '20 weeks'}, {'measure': 'Diastolic function reserve index measured at peak stress with dobutamine', 'timeFrame': '20 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diastolic dysfunction', 'hypertension', 'Statins', 'ACE inhibitor', 'Echocardiography'], 'conditions': ['Diastolic Dysfunction', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '22554359', 'type': 'DERIVED', 'citation': "Beck AL, Otto ME, D'Avila LB, Netto FM, Armendaris MK, Sposito AC. Diastolic function parameters are improved by the addition of simvastatin to enalapril-based treatment in hypertensive individuals. Atherosclerosis. 2012 Jun;222(2):444-8. doi: 10.1016/j.atherosclerosis.2012.03.030. Epub 2012 Apr 3."}]}, 'descriptionModule': {'briefSummary': 'Diastolic dysfunction (DD) is an increasingly frequent condition in hypertensive individuals whose treatment remains unclear. Its presence is related to higher morbidity and mortality independent of blood pressure levels. The aim of this study is to investigate the additive effect of simvastatin on enalapril on DD in hypertensive patients with average cholesterol levels.\n\nFor this aim, hypertensive patients with DD and LDL-cholesterol \\<160 mg/dL will undergo a run-in phase to achieve a systolic blood pressure (SBP) \\<135 mmHg and diastolic blood pressure (DBP) \\<85 mmHg with enalapril. Hydrochlorothiazide could be added when need to achieve SBP or DBP control. Four weeks after reaching the optimum anti-hypertensive regimen patients will be randomized to receive 80 mg simvastatin or placebo for a period of 20 weeks. Echocardiograms will be performed before and after treatment with measurement of left atrial volume, conventional and tissue Doppler velocities in early diastole and late diastole. The evaluation of these will allow to identify changes of DD severity after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men or postmenopausal women aged between 40 and 65 years old\n* normal fasting blood glucose (\\<100 mg/dL) and glucose tolerance test (\\<140 mg/dL)\n* waist circumference \\< 102 cm (men) or \\< 88cm (women)\n* triglycerides \\<150 mg/dL, LDL cholesterol ≤ 160 mg/dl\n* creatinine \\<1.2 mg/dL, sinus rhythm\n* the presence of grade 1 or 2 of DD with an ejection fraction of left ventricle \\> 55%\n* absence of myocardial ischemia during dobutamine stress echocardiography\n\nExclusion Criteria:\n\n* thyroid dysfunction\n* acute or chronic liver disease\n* regular use of 3 or more antihypertensive drugs\n* secondary hypertension\n* symptoms or history of atherosclerotic disease\n* valvular dysfunction\n* LVH 14 and use of statins in the last 6 months'}, 'identificationModule': {'nctId': 'NCT01061450', 'briefTitle': 'Simvastatin and Diastolic Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Brasilia Heart Study Group'}, 'officialTitle': 'Effect of the Addition of Simvastatin to Enalapril in Hypertensive Individuals With Average Cholesterol Levels and Diastolic Dysfunction', 'orgStudyIdInfo': {'id': 'Statin_DD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Simvastatin', 'description': 'Simvastatin 80 mg/day', 'interventionNames': ['Drug: Simvastatin']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['Zocor'], 'description': '80 mg once a day', 'armGroupLabels': ['Simvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 pill once a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000.000', 'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Instituto de Cardiologia do Distrito Federal', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}], 'overallOfficials': [{'name': 'Adenalva LS Beck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'InCor Heart Institute'}, {'name': 'Andrei C Sposito, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Brasilia Medical School, Brasilia, Brazil'}, {'name': 'Maria E Otto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Cardiologia do Distrito Federal, Brasilia, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brasilia Heart Study Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo a Pesquisa do Distrito Federal', 'class': 'UNKNOWN'}, {'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Andrei C Sposito', 'oldOrganization': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil'}}}}