Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

University of Pavia

Status and phase: Unknown; Phase 4

Conditions: Hypertension

Treatments: Drug: Amlodipine + Simvastatin; Drug: Losartan + Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00669435

UNIPV003DIM2008

Details and patient eligibility

About

Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin, resistin and adiponectin; these proteins have a wide range of biological effects and are associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be added to both groups. The aim of this study is to evaluate the effect of losartan and simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or obese hypertensive normocholesterolemic patients with hepatic steatosis.

Enrollment: 75 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gender: 50% Male and 50% female
• Age: 40-80 years
• Race: Caucasian
• Overweight or obese: respectively BMI25-30 kg/m2 or BMI > 30 kg m2
• Hypertensive: PA > 140/90 mmHg
• Normocholesterolemic (LDL< 160 mg/dl HDL > 35 mg/dl)
• Liver steatosis

Exclusion criteria

• other antihypertensive treatment after wash out period of 2 weeks
• abnormal heart rest function (EF < 55%).
• valvular heart disease
• congenital heart disease
• heart failure or prior myocardial infarction
• diabetes
• renal disease
• liver disease
• connective tissue disease
• pregnancy or lactation
• serious adverse experience
• sensitivity to the study drugs or its components
• contraindication from an approved label

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

1

Active Comparator group

Description:

Amlodipine and Simvastatin

Treatment:

Drug: Amlodipine + Simvastatin

2

Experimental group

Description:

Losartan and Simvastatin

Treatment:

Drug: Losartan + Simvastatin