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Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Università degli Studi dell'Insubria.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT00517322
First received: August 15, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 15, 2007
Last Updated: August 15, 2007
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Heart Diseases
Hypertension
Cardiovascular Diseases
Vascular Diseases
Ramipril
Irbesartan
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 17, 2013