NCT00659451

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. 1.left ventricular mass, intraventricular septal thickness, fractional shortening.
  2. 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. 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. 4.aortic strain and distensibility (that is in relation with LVH)
  5. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 16, 2008

Status Verified

April 1, 2008

Enrollment Period

Same day

First QC Date

April 14, 2008

Last Update Submit

April 14, 2008

Conditions

Essential HypertensionDiabetes Mellitus

Keywords

HypertensionDiabetes mellitusHeart

Outcome Measures

Primary Outcomes (1)

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

    Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months

Secondary Outcomes (1)

  • Heterogeneity of myocardial tissue; epicardial adipose tissue measurement

    Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months

Study Arms (2)

2

EXPERIMENTAL

Losartan

Drug: Losartan

1

ACTIVE COMPARATOR

Amlodipine

Drug: Amlodipine

Interventions

LosartanDRUG

tablets; 50, 100 mg; od; 12 months

2
AmlodipineDRUG

tablets; 5, 10 mg; od; 12 months

1

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pavia

Pavia, Italy

RECRUITING

MeSH Terms

Conditions

Essential HypertensionDiabetes MellitusHypertension

Interventions

LosartanAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesDihydropyridinesPyridines

Central Study Contacts

Roberto Fogari

CONTACT

+39 0382 526217

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 16, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2009

Last Updated

April 16, 2008

Record last verified: 2008-04

Locations

IT(1)