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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00659451

Enrollment

100

Registered

2008-04-16

Start date

2008-04-30

Completion date

2009-04-30

Last updated

2008-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Essential Hypertension

Keywords

Hypertension, Diabetes mellitus, Heart

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: 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).

Interventions

DRUGLosartan

tablets; 50, 100 mg; od; 12 months

DRUGAmlodipine

tablets; 5, 10 mg; od; 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Italy

Contacts

Primary ContactRoberto Fogari

+39 0382 526217

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026