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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00659451
• Other study ID #: UNIPV002DIM2008
• Status: Recruiting
• Phase: Phase 3
• First received: April 14, 2008
• Last updated: April 14, 2008
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2008
• Source: University of Pavia
• Contact: Roberto Fogari
• Phone: +39 0382 526217
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Essential Hypertension
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Italy	University of Pavia	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Heterogeneity of myocardial tissue; epicardial adipose tissue measurement		Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months	Yes