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

NCT ID: NCT00659451

Last Updated: 2008-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Essential Hypertension Diabetes Mellitus

Keywords

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Hypertension Diabetes mellitus Heart

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

Losartan

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

tablets; 50, 100 mg; od; 12 months

1

Amlodipine

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

tablets; 5, 10 mg; od; 12 months

Interventions

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Losartan

tablets; 50, 100 mg; od; 12 months

Intervention Type DRUG

Amlodipine

tablets; 5, 10 mg; od; 12 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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University of Pavia

Locations

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University of Pavia

Pavia, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Roberto Fogari

Role: CONTACT

Phone: +39 0382 526217

Facility Contacts

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Paola Preti, MD

Role: primary

Other Identifiers

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UNIPV002DIM2008

Identifier Type: -

Identifier Source: org_study_id