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Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

Primary Purpose

Left Atrial Volume, Hypertensive Heart Disease, Antihypertensive Drugs

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

ramipril

irbesartan

About this trial

This is an interventional treatment trial for Left Atrial Volume focused on measuring left atrial volume, hypertension, ramipril, irbesartan, diastolic function

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Insubria-Department of Clinical MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

treatment with ramipril

treatment with irbesartan

Outcomes

Primary Outcome Measures

left atrial volume

diastolic function

Secondary Outcome Measures

systolic and diastolic blood pressure

Full Information

NCT ID

NCT00517322

First Posted

August 15, 2007

Last Updated

August 15, 2007

Sponsor

Università degli Studi dell'Insubria

1. Study Identification

Unique Protocol Identification Number

NCT00517322

Brief Title

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

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Unknown status

Study Start Date

August 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Università degli Studi dell'Insubria

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Left Atrial Volume, Hypertensive Heart Disease, Antihypertensive Drugs, Diastolic Function, Renin Angiotensin System

Keywords

left atrial volume, hypertension, ramipril, irbesartan, diastolic function

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

treatment with ramipril

Arm Title

Arm Type

Experimental

Arm Description

treatment with irbesartan

Intervention Type

Drug

Intervention Name(s)

ramipril

Intervention Description

ramipril 2.5- 5 mg once daily

Intervention Type

Drug

Intervention Name(s)

irbesartan

Intervention Description

irbesartan 150-300 mg once daily

Primary Outcome Measure Information:

Title

left atrial volume

Time Frame

one year

Title

diastolic function

Time Frame

one year

Secondary Outcome Measure Information:

Title

systolic and diastolic blood pressure

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

anna maria grandi, MD

Organizational Affiliation

Università degli Studi dell'Insubria

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Insubria-Department of Clinical Medicine

City

Varese

ZIP/Postal Code

21100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

anna maria grandi, MD

Phone

+39+332 278594

amgrandi@libero.it

First Name & Middle Initial & Last Name & Degree

anna maria grandi, MD

Phone

+39 + 332 278594

amgrandi@libero.it

First Name & Middle Initial & Last Name & Degree

andrea maria maresca, MD

First Name & Middle Initial & Last Name & Degree

andrea bertolini, MD

First Name & Middle Initial & Last Name & Degree

monica gianni, MD

First Name & Middle Initial & Last Name & Degree

eleonora nicolini, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

8957600

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.

Results Reference

background

PubMed Identifier

12480035

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.

Results Reference

background

PubMed Identifier

15936615

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.

Results Reference

background

PubMed Identifier

16376782

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.

Results Reference

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Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

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