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| Name | Class |
|---|---|
| Fundação de Amparo a Pesquisa do Distrito Federal | UNKNOWN |
| Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior. | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Simvastatin | Experimental | Simvastatin 80 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | 80 mg once a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in E/A ratio and e' wave velocity | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in left atrium volume. | 20 weeks | |
| Changes in left ventricular mass. | 20 weeks | |
| Changes in e´/a´ waves ratio. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adenalva LS Beck, MD | InCor Heart Institute | Principal Investigator |
| Andrei C Sposito, MD, PhD | University of Brasilia Medical School, Brasilia, Brazil | Study Chair |
| Maria E Otto, MD, PhD | Instituto de Cardiologia do Distrito Federal, Brasilia, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Cardiologia do Distrito Federal | BrasÃlia | Federal District | 70000.000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22554359 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | 1 pill once a day |
|
| 20 weeks |
| Changes in mitral deceleration time. | 20 weeks |
| Changes in the ratio of mitral inflow velocity to annular relaxation velocity. | 20 weeks |
| Changes in mitral annulus systolic velocity | 20 weeks |
| Diastolic function reserve index measured at peak stress with dobutamine | 20 weeks |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |