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

University of Pavia

Status and phase: Unknown; Phase 3

Conditions: Diabetes Mellitus; Essential Hypertension

Treatments: Drug: Losartan; Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT00659451

UNIPV002DIM2008

Details and patient eligibility

About

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).

Enrollment: 100 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

2

Experimental group

Description:

Losartan

Treatment:

Drug: Losartan

1

Active Comparator group

Description:

Amlodipine

Treatment:

Drug: Amlodipine