Left Atrial Remodelling in Hypertension: Effects of Ramip... | NCT00517322

Studies
Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

NCT00517322

Sponsor

Università degli Studi dell'Insubria

Status

Unknown status

Last Update Posted

Aug 16, 2007Estimated

Enrollment

80Estimated

Phase

Phase 4

Conditions

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

Interventions

ramipril
irbesartan

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

Aug 2010Estimated

First Submitted Date

Aug 15, 2007

First Submission Date that Met QC Criteria

Aug 15, 2007

First Posted Date

Aug 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2007

Last Update Posted Date

Aug 16, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	treatment with ramipril	Drug: ramipril
2	Experimental	treatment with irbesartan	Drug: irbesartan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ramipril	Drug	ramipril 2.5- 5 mg once daily	1
irbesartan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
left atrial volume		one year
diastolic function		one year

Secondary Outcomes

Measure	Description	Time Frame
systolic and diastolic blood pressure		one year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
anna maria grandi, MD	Università degli Studi dell'Insubria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Insubria-Department of Clinical Medicine	Recruiting	Varese		21100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8957600	Background	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.
12480035	Background	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D001713	Biphenyl Compounds

ID	Term
D017257	Ramipril
D000077405	Irbesartan