Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

August 15, 2007 updated by: Università degli Studi dell'Insubria
Aim of the study is to compare in hypertensive patients the effect of one year therapy with ACE-inhibitor (RAMIPRIL) or angiotensin II receptor blocker (IRBESARTAN) on left atrial remodelling and diastolic function.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Varese, Italy, 21100
        • Recruiting
        • University of Insubria-Department of Clinical Medicine
        • Contact:
        • Sub-Investigator:
          • andrea bertolini, MD
        • Sub-Investigator:
          • monica gianni, MD
        • Sub-Investigator:
          • eleonora nicolini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:·

  • mild to moderate essential hypertension
  • no antihypertensive treatment
  • good quality echocardiogram

Exclusion Criteria:

  • cardiovascular diseases (AMI, stroke o TIA)
  • heart failure, valvular heart disease
  • diabetes
  • secondary hypertension
  • atrial fibrillation
  • hepatic and renal severe failure
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
treatment with ramipril
Drug: ramipril
ramipril 2.5- 5 mg once daily
Experimental: 2
treatment with irbesartan
Drug: irbesartan
irbesartan 150-300 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
diastolic function
Time Frame: one year
one year
left atrial volume
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
systolic and diastolic blood pressure
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

August 15, 2007

First Submitted That Met QC Criteria

August 15, 2007

First Posted (Estimate)

August 16, 2007

Study Record Updates

Last Update Posted (Estimate)

August 16, 2007

Last Update Submitted That Met QC Criteria

August 15, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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