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Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by Università degli Studi dell'Insubria.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517322
First Posted: August 16, 2007
Last Update Posted: August 16, 2007
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.
Information provided by:
Università degli Studi dell'Insubria
  Purpose
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 Intervention Phase
Left Atrial Volume Hypertensive Heart Disease Antihypertensive Drugs Diastolic Function Renin Angiotensin System Drug: ramipril Drug: irbesartan Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • left atrial volume [ Time Frame: one year ]
  • diastolic function [ Time Frame: one year ]

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

Estimated Enrollment: 80
Study Start Date: August 2007
Estimated Study Completion Date: August 2010
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00517322


Locations
Italy
University of Insubria-Department of Clinical Medicine Recruiting
Varese, Italy, 21100
Contact: anna maria grandi, MD    +39+332 278594    amgrandi@libero.it   
Contact: anna maria grandi, MD    +39 + 332 278594    amgrandi@libero.it   
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
Investigators
Principal Investigator: anna maria grandi, MD Università degli Studi dell'Insubria
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00517322     History of Changes
Other Study ID Numbers: 1112
First Submitted: August 15, 2007
First Posted: August 16, 2007
Last Update Posted: August 16, 2007
Last Verified: August 2007

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

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