The Effect of Angiotensin II Type 1 Receptor Antagonists... | NCT01670903

Studies
The Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive Patients

NCT01670903

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Aug 22, 2012Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Aneurysm
Hypertension

Interventions

Not provided

Countries

Israel

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 2012

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

May 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 19, 2012

First Submission Date that Met QC Criteria

Aug 19, 2012

First Posted Date

Aug 22, 2012Estimated

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 19, 2012

Last Update Posted Date

Aug 22, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Abdominal aortic aneurysm (AAA) is a common disease that develops from degeneration of the aortic wall. The natural history of AAA is gradual expansion and if left untreated may result in rupture and death. The mechanism of the development of this disease is unknown however it appears to be multifactorial and possibly related to degradation processes within the arterial wall. There is growing evidence that Angiotensin receptor blockers ( ARBS) may have an inhibitory effect on remodelling processes within the arterial wall, thus inhibiting degeneration of the vessel wall.

Study hypothesis: ARBS are associated with smaller diameters of aortas among hypertensive patients, and are associated with a lower rate of aortic expansion compared to other antihypertensive drugs.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARBs		Hypertensive patients treated with ARBs
ACE inhibitors		Hypertensive patients treated with ACE inhibitors
non ARB/ACE		Hypertensive patients treated with non ARBs or ACE inhibitors meds

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

medically treated hypertensive patients, ages 50-80

Exclusion Criteria:

pregnant women
patients previously treated for aortic disease
unable to sign informed consent, minors

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

medically treated hypertensive patients, ages 50-80

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel Silverberg, MD	Contact	035302712		Daniel.Silverberg@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Daniel Silverberg, MD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center	Recruiting	Tel Litwinsky			Israel

Condition Browse Module

MeSH Terms

ID	Term
D000783	Aneurysm
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided