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

Primary Purpose

Essential Hypertension, Diabetes Mellitus

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Losartan
Amlodipine
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Hypertension, Diabetes mellitus, Heart

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of PaviaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2

1

Arm Description

Losartan

Amlodipine

Outcomes

Primary Outcome Measures

Left ventricular mass, intraventricular septal thickness, fractional shortening; myocardial qualitative and diastolic function alteration; aortic strain and distensibility.

Secondary Outcome Measures

Heterogeneity of myocardial tissue; epicardial adipose tissue measurement

Full Information

First Posted
April 14, 2008
Last Updated
April 14, 2008
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT00659451
Brief Title
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

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pavia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: left ventricular mass, intraventricular septal thickness, fractional shortening. 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 alteration of diastolic function as studied by Doppler flow velocities across the mitral valve (Pulse Wave Doppler) and pulse wave Tissue Doppler Imaging parameters aortic strain and distensibility (that is in relation with LVH) 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension, Diabetes Mellitus
Keywords
Hypertension, Diabetes mellitus, Heart

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
Losartan
Arm Title
1
Arm Type
Active Comparator
Arm Description
Amlodipine
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
tablets; 50, 100 mg; od; 12 months
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
tablets; 5, 10 mg; od; 12 months
Primary Outcome Measure Information:
Title
Left ventricular mass, intraventricular septal thickness, fractional shortening; myocardial qualitative and diastolic function alteration; aortic strain and distensibility.
Time Frame
Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Heterogeneity of myocardial tissue; epicardial adipose tissue measurement
Time Frame
Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Fogari
Phone
+39 0382 526217
Facility Information:
Facility Name
University of Pavia
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Preti, MD
Phone
+39 0382 526217
First Name & Middle Initial & Last Name & Degree
Paola Preti

12. IPD Sharing Statement

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

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