Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan - Full Text View

Sponsor:	Università degli Studi dell'Insubria
Information provided by:	Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:	NCT00517322

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 IV

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:

MedlinePlus related topics: Blood Pressure Medicines Heart Diseases High Blood Pressure

Drug Information available for: Ramipril Irbesartan

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:

Matsuda M, Matsuda Y. Mechanism of left atrial enlargement related to ventricular diastolic impairment in hypertension. Clin Cardiol. 1996 Dec;19(12):954-9.

Tsang TS, Barnes ME, Gersh BJ, Bailey KR, Seward JB. Left atrial volume as a morphophysiologic expression of left ventricular diastolic dysfunction and relation to cardiovascular risk burden. Am J Cardiol. 2002 Dec 15;90(12):1284-9.

Healey JS, Baranchuk A, Crystal E, Morillo CA, Garfinkle M, Yusuf S, Connolly SJ. Prevention of atrial fibrillation with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: a meta-analysis. J Am Coll Cardiol. 2005 Jun 7;45(11):1832-9.

Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. No abstract available.

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 February 09, 2012