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Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Losartan + Simvastatin
Amlodipine + Simvastatin
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Essential hypertension, Liver steatosis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of PaviaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Amlodipine and Simvastatin

Losartan and Simvastatin

Outcomes

Primary Outcome Measures

All patients will undergo anthropometric evaluation and abdominal ultrasonography (performed by the same examiner); will be taken routine liver US and US measurement of visceral and subcutaneous fat.

Secondary Outcome Measures

Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR

Full Information

First Posted
April 25, 2008
Last Updated
April 28, 2008
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT00669435
Brief Title
Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis
Official Title
Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pavia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Essential hypertension, Liver steatosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Amlodipine and Simvastatin
Arm Title
2
Arm Type
Experimental
Arm Description
Losartan and Simvastatin
Intervention Type
Drug
Intervention Name(s)
Losartan + Simvastatin
Intervention Description
tablets; 50, 100 mg; od; 12 months tablets; 20 mg; od; 6 months
Intervention Type
Drug
Intervention Name(s)
Amlodipine + Simvastatin
Intervention Description
tablets; 5, 10 mg; od; 12 months tablets; 20 mg; od; 6 months
Primary Outcome Measure Information:
Title
All patients will undergo anthropometric evaluation and abdominal ultrasonography (performed by the same examiner); will be taken routine liver US and US measurement of visceral and subcutaneous fat.
Time Frame
Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
Secondary Outcome Measure Information:
Title
Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR
Time Frame
Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Derosa
Phone
39-038-250-2614
Facility Information:
Facility Name
University of Pavia
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Derosa, MD
Phone
39-038-250-2614

12. IPD Sharing Statement

Learn more about this trial

Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

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