Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517322
Recruitment Status : Unknown
Verified August 2007 by Università degli Studi dell'Insubria.
Recruitment status was:  Recruiting
First Posted : August 16, 2007
Last Update Posted : August 16, 2007
Information provided by:
Università degli Studi dell'Insubria

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Left Atrial Volume Hypertensive Heart Disease Antihypertensive Drugs Diastolic Function Renin Angiotensin System Drug: ramipril Drug: irbesartan Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan
Study Start Date : August 2007
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. left atrial volume [ Time Frame: one year ]
  2. diastolic function [ Time Frame: one year ]

Secondary Outcome Measures :
  1. systolic and diastolic blood pressure [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00517322

University of Insubria-Department of Clinical Medicine Recruiting
Varese, Italy, 21100
Contact: anna maria grandi, MD    +39+332 278594   
Contact: anna maria grandi, MD    +39 + 332 278594   
Sub-Investigator: andrea maria maresca, MD         
Sub-Investigator: andrea bertolini, MD         
Sub-Investigator: monica gianni, MD         
Sub-Investigator: eleonora nicolini, MD         
Sponsors and Collaborators
Università degli Studi dell'Insubria
Principal Investigator: anna maria grandi, MD Università degli Studi dell'Insubria

Publications: Identifier: NCT00517322     History of Changes
Other Study ID Numbers: 1112
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: August 16, 2007
Last Verified: August 2007

Keywords provided by Università degli Studi dell'Insubria:
left atrial volume
diastolic function

Additional relevant MeSH terms:
Heart Diseases
Atrial Remodeling
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Pathologic Processes
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists