Effects Of Losartan On Myocardial Structure In Diabetic Hypertensive Patients With Left Ventricular
Information source: University of Pavia
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension; Diabetes Mellitus
Intervention: Losartan (Drug); Amlodipine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Pavia Overall contact:
Roberto Fogari, Phone: +39 0382 526217
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).
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Left ventricular mass, intraventricular septal thickness, fractional shortening; myocardial qualitative and diastolic function alteration; aortic strain and distensibility.
Secondary outcome: Heterogeneity of myocardial tissue; epicardial adipose tissue measurement
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Roberto Fogari, Phone: +39 0382 526217
University of Pavia, Pavia, Italy; Recruiting
Paola Preti, MD, Phone: +39 0382 526217
Paola Preti, Sub-Investigator
Additional Information
Starting date: April 2008
Ending date: April 2009
Last updated: April 14, 2008
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