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

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ClinicalTrials.gov Identifier: NCT00659451
Recruitment Status : Unknown
Verified April 2008 by University of Pavia.
Recruitment status was:  Recruiting
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
Sponsor:
Information provided by:
University of Pavia

Study Description
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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).

Condition or disease Intervention/treatment Phase
Essential Hypertension Diabetes Mellitus Drug: Losartan Drug: Amlodipine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2008
Actual Primary Completion Date : April 2008
Estimated Study Completion Date : April 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 2
Losartan
 Drug: Losartan
tablets; 50, 100 mg; od; 12 months
Active Comparator: 1
Amlodipine
 Drug: Amlodipine
tablets; 5, 10 mg; od; 12 months


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659451


Contacts
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Contact: Roberto Fogari +39 0382 526217

Locations
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Italy
University of Pavia Recruiting
Pavia, Italy
Contact: Paola Preti, MD    +39 0382 526217      
Sub-Investigator: Paola Preti         
Sponsors and Collaborators
University of Pavia
More Information
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Responsible Party: Paola Preti/MD, University of Pavia
ClinicalTrials.gov Identifier: NCT00659451     History of Changes
Other Study ID Numbers: UNIPV002DIM2008
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: April 2008
Keywords provided by University of Pavia:
Hypertension
Diabetes mellitus
Heart
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Losartan
Amlodipine
 Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists