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| Sponsors and Collaborators: |
Hospital Universitario 12 de Octubre Merck Sharp & Dohme |
|---|---|
| Information provided by: | Hospital Universitario 12 de Octubre |
| ClinicalTrials.gov Identifier: | NCT00621127 |
Purpose
Experimental studies have showed that statins reduce left ventricular hypertrophy. The main objective is to observe the reduction of left ventricular hypertrophy with statins in hypertensive patients. The hypothesis is that patients treated with statins will have a reduction of at least 10% compared with patients treated only with antihypertensive treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Left Ventricular Hypertrophy Hypercholesterolemia Hypertension |
Drug: Valsartan plus pravastatin Drug: Valsartan plus simvastatin Drug: Valsartan plus simvastatin plus ezetimib Drug: Only valsartan |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients |
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: Valsartan plus pravastatin
Valsartan 80mg plus pravastatin 40 mg PO every day for one year
|
| 2: Active Comparator |
Drug: Valsartan plus simvastatin
Valsartan 80mg plus simvastatin 40mg PO every day for one year
|
| 3: Active Comparator |
Drug: Valsartan plus simvastatin plus ezetimib
Valsartan 80mg plus simvastatin 40mg / 10mg ezetimib PO every day for one year
|
| 4: No Intervention |
Drug: Only valsartan
Valsartan 80mg PO every day for one year
|
Experimental studies have showed that statins reduce left ventricular hypertrophy. The main objective is to observe the reduction of left ventricular hypertrophy with statins in hypertensive patients. The hypothesis is that patients treated with statins will have a reduction of at least 10% compared with patients treated only with antihypertensive treatment. The study will be conducted at Cardiovascular Unit Hospital 1o de october in Mexico City. Patients must have hypertension grade 2 according to the European Hypertension Guides, and must have LDL-C >130mg/dl. Patient will be assigned randomly to four arms of treatment, and will be follow up for one year.
Left ventricular mass will be measured every 6 months, and LDL-C will be measured every 2 months.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Alejandra Meaney, MD, PhD | 52 55 57544512 | ameaney@cinvestav.mx |
| Mexico | |
| Cardiovascular Unit Hospital 1o de October | Recruiting |
| Mexico City, Mexico, 07060 | |
| Contact: Alejandra Meaney, MD, PhD 52 55 57544512 ameaney@cinvestav.mx | |
| Study Director: | Alejandra Meaney, MD, PhD | Unaffiliated |
| Principal Investigator: | Gustavo Solache, MD | Unaffiliated |
More Information
| Responsible Party: | Cardiologist staff ( MD, PHD Alejandra Meaney ) |
| Study ID Numbers: | REV 284/07 |
| Study First Received: | February 11, 2008 |
| Last Updated: | February 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00621127 History of Changes |
| Health Authority: | Mexico: Federal Commission for Sanitary Risks Protection |
|
Left ventricular hypertrophy Statins Hypercholesterolemia |
|
Antimetabolites Pathological Conditions, Anatomical Hypertrophy, Left Ventricular Hyperlipidemias Metabolic Diseases Heart Diseases Simvastatin Antilipemic Agents Vascular Diseases Ezetimibe Cardiovascular Agents Anticholesteremic Agents |
Antihypertensive Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pravastatin Hypertrophy Hypercholesterolemia Cardiomegaly Metabolic Disorder Valsartan Dyslipidemias Hypertension Lipid Metabolism Disorders |
|
Pathological Conditions, Anatomical Antimetabolites Molecular Mechanisms of Pharmacological Action Ezetimibe Pravastatin Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Valsartan Hypertrophy, Left Ventricular Heart Diseases Metabolic Diseases Hyperlipidemias |
Simvastatin Antilipemic Agents Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Anticholesteremic Agents Antihypertensive Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Hypertrophy Cardiomegaly Lipid Metabolism Disorders Hypertension |
