Effects Of Losartan On Myocardial Structure In Diabetic Hypertensive Patients With Left Ventricular - Full Text View

Sponsor:	University of Pavia
Information provided by:	University of Pavia
ClinicalTrials.gov Identifier:	NCT00659451

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:

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).

Condition	Intervention	Phase
Essential Hypertension Diabetes Mellitus	Drug: Losartan Drug: Amlodipine	Phase III

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Losartan Losartan potassium

U.S. FDA Resources

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

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 February 09, 2012