NCT00517322

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 16, 2007

Status Verified

August 1, 2007

First QC Date

August 15, 2007

Last Update Submit

August 15, 2007

Conditions

Left Atrial VolumeHypertensive Heart DiseaseAntihypertensive DrugsDiastolic FunctionRenin Angiotensin System

Keywords

left atrial volumehypertensionramiprilirbesartandiastolic function

Outcome Measures

Primary Outcomes (2)

  • left atrial volume

    one year

  • diastolic function

    one year

Secondary Outcomes (1)

  • systolic and diastolic blood pressure

    one year

Study Arms (2)

1

EXPERIMENTAL

treatment with ramipril

Drug: ramipril

2

EXPERIMENTAL

treatment with irbesartan

Drug: irbesartan

Interventions

ramiprilDRUG

ramipril 2.5- 5 mg once daily

1
irbesartanDRUG

irbesartan 150-300 mg once daily

2

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild to moderate essential hypertension
  • no antihypertensive treatment
  • good quality echocardiogram

You may not qualify if:

  • cardiovascular diseases (AMI, stroke o TIA)
  • heart failure, valvular heart disease
  • diabetes
  • secondary hypertension
  • atrial fibrillation
  • hepatic and renal severe failure
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Insubria-Department of Clinical Medicine

Varese, 21100, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 8957600BACKGROUND

  • 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.

    PMID: 12480035BACKGROUND

  • 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.

    PMID: 15936615BACKGROUND

  • 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.

    PMID: 16376782BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

RamiprilIrbesartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingPolycyclic Compounds

Study Officials

  • anna maria grandi, MD

    Università degli Studi dell'Insubria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2007

First Posted

August 16, 2007

Study Start

August 1, 2007

Study Completion

August 1, 2010

Last Updated

August 16, 2007

Record last verified: 2007-08

Locations

IT(1)