Clinical trial NCT00659451: Effects Of Losartan On Myocardial Structure In Diabetic Hypertensive Patients With Left Ventricular
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Essential Hypertension
Diabetes Mellitus
Keywords: Hypertension
Diabetes mellitus
Heart
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2008-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular mass, intraventricular septal thickness, fractional shortening; myocardial qualitative and diastolic function alteration; aortic strain and distensibility.
timeFrame: Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months
Secondary outcomes:
measure: Heterogeneity of myocardial tissue; epicardial adipose tissue measurement
timeFrame: Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: University of Pavia
Study officials:
References: