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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by University of Pavia.
Recruitment status was:  Recruiting
Information provided by:
University of Pavia Identifier:
First received: April 14, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

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 Intervention Phase
Essential Hypertension Diabetes Mellitus Drug: Losartan Drug: Amlodipine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Pavia:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Drug: Losartan
tablets; 50, 100 mg; od; 12 months
Active Comparator: 1
Drug: Amlodipine
tablets; 5, 10 mg; od; 12 months


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00659451

Contact: Roberto Fogari +39 0382 526217

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

Responsible Party: Paola Preti/MD, University of Pavia Identifier: NCT00659451     History of Changes
Other Study ID Numbers: UNIPV002DIM2008
Study First Received: April 14, 2008
Last Updated: April 14, 2008

Keywords provided by University of Pavia:
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on August 22, 2017