Official Title: “Effects Of Losartan On Myocardial Structure And Function And On Epicardial Fat Deposition In Diabetic Hypertensive Patients With Left Ventricular: Qualitative And Quantitative Alteration”

The anthypertensive treatment with Losartan may have benefits beyond blood pressure reduction on myocardial structure and function in hypertensive diabetic patients. We will evaluate the effect of losartan treatment on structural characteristics of myocardium in hypertensive diabetic patients:

1. left ventricular mass, intraventricular septal thickness, fractional shortening.

2. myocardial qualitative alteration and heterogeneity of myocardial tissue that describes myocardial texture and echodensity, related to collagen deposition; myocardial qualitative alteration will be evaluate by ultrasonic myocardial integrated backscatter signals (IBS) both as peak end diastolic signal intensity and as cardiac cyclic variation

3. alteration of diastolic function as studied by Doppler flow velocities across the mitral valve (Pulse Wave Doppler) and pulse wave Tissue Doppler Imaging parameters

4. aortic strain and distensibility (that is in relation with LVH)

5. epicardial adipose tissue measurement (this parameter is related to the visceral fat and may be an easy method to indicate patients with high cardiovascular risk).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Losartan
  • tablets; 50, 100 mg; od; 12 months
• Drug: Amlodipine
  • tablets; 5, 10 mg; od; 12 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 2
  • Losartan
• Active Comparator: 1
  • Amlodipine

Primary Measures

• Left ventricular mass, intraventricular septal thickness, fractional shortening; myocardial qualitative and diastolic function alteration; aortic strain and distensibility.
  • Time Frame: Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months
    Safety Issue?: Yes

Secondary Measures

• Heterogeneity of myocardial tissue; epicardial adipose tissue measurement
  • Time Frame: Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months
    Safety Issue?: Yes

Inclusion Criteria:

• Gender: 50% Male and 50 % female
• Age: 40-80 years
• Race: caucasian
• Well controlled type II Diabetes : fasting glicemia < 126 mg/dl in two different determinantion or any non fasting glicemia > 200 mg/dl; HbA1c < 7%
• Mild to moderate hypertension (BP>130/80mmHg; <160/100mmHg)
• Left ventricular hypertrophy (LVMI > 131/110 g/m2 in males/females respectively)

Exclusion Criteria:

• other anthypertensive 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
• renal disease
• liver disease
• connective tissue disease
• pregnancy or lactation
• sensitivity to the study drugs
• contraindication from an approved label

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pavia

Overall Clinical Trial Officials and Contacts

Overall Contact: Roberto Fogari +39 0382 526217 

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00659451

Study ID Number: UNIPV002DIM2008

ClinicalTrials.gov Identifier: NCT00659451

Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health