Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients - Full Text View

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol High Blood Pressure Statins

Drug Information available for: Valsartan Pravastatin Pravastatin sodium Simvastatin Ezetimibe

U.S. FDA Resources

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

Further study details as provided by Hospital Universitario 12 de Octubre:

Primary Outcome Measures:

VENTRICULAR MASS [ Time Frame: every 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

LDL cholesterol levels [ Time Frame: every 2 months ] [ Designated as safety issue: No ]

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

Detailed Description:

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621127

Contacts

Contact: Alejandra Meaney, MD, PhD

52 55 57544512

ameaney@cinvestav.mx

Locations

Mexico
Cardiovascular Unit Hospital 1o de October	Recruiting
Mexico City, Mexico, 07060
Contact: Alejandra Meaney, MD, PhD 52 55 57544512 ameaney@cinvestav.mx

Sponsors and Collaborators

Hospital Universitario 12 de Octubre

Merck Sharp & Dohme

Investigators

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
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Hospital Universitario 12 de Octubre:

Left ventricular hypertrophy
Statins
Hypercholesterolemia

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hypertrophy, Left Ventricular
Hyperlipidemias
Metabolic Diseases
Heart Diseases
Simvastatin
Vascular Diseases
Ezetimibe
Pravastatin

Hypertrophy
Metabolic disorder
Hypercholesterolemia
Cardiomegaly
Valsartan
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors
Cardiovascular Diseases

Cardiovascular Agents
Anticholesteremic Agents
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009