Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

Hypertensive Heart Disease Clinical Trial

Official title:

Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00517322
• Other study ID #: 1112
• Status: Recruiting
• Phase: Phase 4
• First received: August 15, 2007
• Last updated: August 15, 2007
• Start date: August 2007
• Est. completion date: August 2010

Study information

• Verified date: August 2007
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antihypertensive Drugs
• Atrial Remodeling
• Diastolic Function
• Heart Diseases
• Hypertension
• Hypertensive Heart Disease
• Left Atrial Volume
• Renin Angiotensin System

Intervention

Drug:
• ramipril
ramipril 2.5- 5 mg once daily
• irbesartan
irbesartan 150-300 mg once daily

Locations

Country	Name	City	State
Italy	University of Insubria-Department of Clinical Medicine	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left atrial volume		one year
Primary	diastolic function		one year
Secondary	systolic and diastolic blood pressure		one year