Official Title: “Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Valsartan plus pravastatin
  • Valsartan 80mg plus pravastatin 40 mg PO every day for one year
• Drug: Valsartan plus simvastatin
  • Valsartan 80mg plus simvastatin 40mg PO every day for one year
• Drug: Valsartan plus simvastatin plus ezetimib
  • Valsartan 80mg plus simvastatin 40mg / 10mg ezetimib PO every day for one year
• Drug: Only valsartan
  • Valsartan 80mg PO every day for one year

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2
• Active Comparator: 3
• No Intervention: 4

Primary Measures

• VENTRICULAR MASS
  • Time Frame: every 6 months
    Safety Issue?: No

Secondary Measures

• LDL cholesterol levels
  • Time Frame: every 2 months
    Safety Issue?: No

Inclusion Criteria:

• Both genders
• Outpatients age > or = 18 years
• Systolic hypertension >140 < 180
• Diastolic hypertension >90 < 110
• Left ventricular hypertrophy > 104g/mBMI in women > 116g/mBMI
• Without treatment wits statins
• Informed Consent signed

Exclusion Criteria:

• Diabetes Mellitus
• Familial hypercholesterolemia
• LDL-C >190mg/dL
• Triglycerides >250mg/dL
• Ischemic heart disease
• Secondary Hypertension
• Intolerance to valsartan or statins
• Abnormalities in hepatic liver function
• CPK three times UNL
• Creatinine > 3mg /dL
• Patients treated with statins

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hospital Universitario 12 de Octubre

Overall Clinical Trial Officials and Contacts

Alejandra Meaney, MD, PhD Study Director Unaffiliated  

Overall Contact: Alejandra Meaney, MD, PhD 52 55 57544512 ameaney@cinvestav.mx

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00621127

Study ID Number: REV 284/07

ClinicalTrials.gov Identifier: NCT00621127

Health Authority: Mexico: Federal Commission for Sanitary Risks Protection