Effects Of Losartan On Myocardial Structure In Diabetic Hypertensive Patients With Left Ventricular

Sponsor

University of Pavia (Other)

Overall Status

Unknown status

CT.gov ID

NCT00659451

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

left ventricular mass, intraventricular septal thickness, fractional shortening.
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
alteration of diastolic function as studied by Doppler flow velocities across the mitral valve (Pulse Wave Doppler) and pulse wave Tissue Doppler Imaging parameters
aortic strain and distensibility (that is in relation with LVH)
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).

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension Diabetes Mellitus	Drug: Losartan Drug: Amlodipine	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Apr 1, 2008

Anticipated Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2 Losartan	Drug: Losartan tablets; 50, 100 mg; od; 12 months
Active Comparator: 1 Amlodipine	Drug: Amlodipine tablets; 5, 10 mg; od; 12 months

Arm

Intervention/Treatment

Experimental: 2

Losartan

Drug: Losartan

tablets; 50, 100 mg; od; 12 months

Active Comparator: 1

Amlodipine

Drug: Amlodipine

tablets; 5, 10 mg; od; 12 months

Outcome Measures

Primary Outcome Measures

Left ventricular mass, intraventricular septal thickness, fractional shortening; myocardial qualitative and diastolic function alteration; aortic strain and distensibility. [Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months]

Secondary Outcome Measures

Heterogeneity of myocardial tissue; epicardial adipose tissue measurement [Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)