Clinical trial NCT00517322: Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan
Official title: Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Left Atrial Volume
Hypertensive Heart Disease
Antihypertensive Drugs
Diastolic Function
Renin Angiotensin System
Keywords: left atrial volume
hypertension
ramipril
irbesartan
diastolic function
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2007-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: left atrial volume
timeFrame: one year
measure: diastolic function
timeFrame: one year
Secondary outcomes:
measure: systolic and diastolic blood pressure
timeFrame: one year
Other outcomes:
Locations:
city: Varese
country: Italy
facility: University of Insubria-Department of Clinical Medicine
Study officials:
affiliation: Università degli Studi dell'Insubria
name: anna maria grandi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matsuda M, Matsuda Y. Mechanism of left atrial enlargement related to ventricular diastolic impairment in hypertension. Clin Cardiol. 1996 Dec;19(12):954-9. doi: 10.1002/clc.4960191211.
citation: 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. doi: 10.1016/s0002-9149(02)02864-3.
citation: 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. doi: 10.1016/j.jacc.2004.11.070.
citation: 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. doi: 10.1016/j.echo.2005.10.005. No abstract available.