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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by University of Pavia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pavia
ClinicalTrials.gov Identifier:
NCT00659451
First received: April 14, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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
Losartan
Drug: Losartan
tablets; 50, 100 mg; od; 12 months
Active Comparator: 1
Amlodipine
Drug: Amlodipine
tablets; 5, 10 mg; od; 12 months

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659451

Contacts
Contact: Roberto Fogari +39 0382 526217

Locations
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

No publications provided

Responsible Party: Paola Preti/MD, University of Pavia
ClinicalTrials.gov Identifier: NCT00659451     History of Changes
Other Study ID Numbers: UNIPV002DIM2008
Study First Received: April 14, 2008
Last Updated: April 14, 2008
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Pavia:
Hypertension
Diabetes mellitus
Heart

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Losartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 28, 2014