The Efficacy of Color-Doppler Ultrasonography to Assess t... | NCT00470769

Studies
The Efficacy of Color-Doppler Ultrasonography to Assess the Renal Blood Flow With the Estimation of GFR

NCT00470769

Sponsor

University of Roma La Sapienza

Status

Unknown status

Last Update Posted

May 8, 2007Estimated

Enrollment

2,006Estimated

Phase

Not provided

Conditions

Hypertension
Renal Failure

Interventions

Color-Doppler Ultrasound, 99mTc-DTPA scintigraphy

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

May 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

Sep 2006

Primary Completion Date

Not provided

Completion Date

May 2007Estimated

First Submitted Date

May 7, 2007

First Submission Date that Met QC Criteria

May 7, 2007

First Posted Date

May 8, 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

May 7, 2007

Last Update Posted Date

May 8, 2007Estimated

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

It is generally assumed that renal blood flow is symmetric in the absence of renal artery stenosis. The importance of studying the function of both kidneys separately is because it cannot be assumed that they are functionally equal.The aim of the present study is to evaluate whether this is really in patients with essential hypertension and/or moderate kidneys loss.

Detailed Description

To validate color Doppler ultrasonography of renal arteries for the assessment of renal blood flow (RBF), we comparing left and right RBF estimates and their sum (total RBF) by echo-Doppler with data obtained by 99mTc-DTPA scintigraphy in 50 patients with hypertension and/or moderate renal failure, compared with 30 normal control subjects.

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

2,006Estimated

Name	Type	Description	Arm Group Labels	Other Names
Color-Doppler Ultrasound, 99mTc-DTPA scintigraphy	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with hypertension
Patients with moderate renal insufficiency
Normal subjects

Exclusion Criteria:

Patients with solitary kidney function
Patients with renal artery stenosis
Patients underwent renal angioplasty and stenting

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rosario Cianci, MD	Contact	+39335206441		ciancirosario@tin.it

Overall Officials

Name	Affiliation	Role
Rosario Cianci, MD	Department Of Clinic Medicine, Chair of Nephrology	Principal Investigator
Giorgio Fuiano, MD	University of Catanzaro	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Giorgio Fuiano	Recruiting	Catanzaro		88020	Italy
University of Rome La Sapienza

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided