Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
55 participants
INTERVENTIONAL
2006-11-30
2009-08-31
Brief Summary
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For 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
1 pill once a day
Simvastatin
Simvastatin 80 mg/day
Simvastatin
80 mg once a day
Interventions
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Simvastatin
80 mg once a day
Placebo
1 pill once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* normal fasting blood glucose (\<100 mg/dL) and glucose tolerance test (\<140 mg/dL)
* waist circumference \< 102 cm (men) or \< 88cm (women)
* triglycerides \<150 mg/dL, LDL cholesterol ≤ 160 mg/dl
* creatinine \<1.2 mg/dL, sinus rhythm
* the presence of grade 1 or 2 of DD with an ejection fraction of left ventricle \> 55%
* absence of myocardial ischemia during dobutamine stress echocardiography
Exclusion Criteria
* acute or chronic liver disease
* regular use of 3 or more antihypertensive drugs
* secondary hypertension
* symptoms or history of atherosclerotic disease
* valvular dysfunction
* LVH 14 and use of statins in the last 6 months
40 Years
65 Years
ALL
No
Sponsors
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Fundação de Amparo a Pesquisa do Distrito Federal
UNKNOWN
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Brasilia Heart Study Group
OTHER
Responsible Party
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Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil
Principal Investigators
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Adenalva LS Beck, MD
Role: PRINCIPAL_INVESTIGATOR
InCor Heart Institute
Andrei C Sposito, MD, PhD
Role: STUDY_CHAIR
University of Brasilia Medical School, Brasilia, Brazil
Maria E Otto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Cardiologia do Distrito Federal, Brasilia, Brazil
Locations
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Instituto de Cardiologia do Distrito Federal
Brasília, Federal District, Brazil
Countries
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References
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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.
Other Identifiers
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Statin_DD
Identifier Type: -
Identifier Source: org_study_id
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