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Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

NCT ID: NCT00517322

Last Updated: 2007-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

treatment with ramipril

Group Type EXPERIMENTAL

ramipril

Intervention Type DRUG

ramipril 2.5- 5 mg once daily

2

treatment with irbesartan

Group Type EXPERIMENTAL

irbesartan

Intervention Type DRUG

irbesartan 150-300 mg once daily

Interventions

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ramipril

ramipril 2.5- 5 mg once daily

Intervention Type DRUG

irbesartan

irbesartan 150-300 mg once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Principal Investigators

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anna maria grandi, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria

Locations

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University of Insubria-Department of Clinical Medicine

Varese, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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anna maria grandi, MD

Role: primary

[email protected]
+39+332 278594

anna maria grandi, MD

Role: backup

[email protected]
+39 + 332 278594

References

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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.

Reference Type BACKGROUND
PMID: 8957600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12480035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15936615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16376782 (View on PubMed)

Other Identifiers

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1112

Identifier Type: -

Identifier Source: org_study_id