Is Orthostatic Hypotension Associated With Nondipping Hyp... | NCT00491231

Studies
Is Orthostatic Hypotension Associated With Nondipping Hypertension

NCT00491231

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Nov 19, 2007Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Orthostatic Hypotension
Nondipping 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

Nov 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

Jul 2007

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Jun 25, 2007

First Submission Date that Met QC Criteria

Jun 25, 2007

First Posted Date

Jun 26, 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

Nov 15, 2007

Last Update Posted Date

Nov 19, 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

The aim of the study is to evaluate whether orthostatic hypotension is associated with nondipping hypertension.

Methods and patients: 400 subjects who are referred for 24hABPM will be filled questioner regarding their medical background and medications. All patients will be subjected to orthostatic test before connection to the 24 ABPM. The orthostatic changes in blood pressure and heart rate will be correlated to the changes in blood pressure and heart rate from day to night as recorded by the 24H ABPM.

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

400Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients who are referred for ABPM

Exclusion Criteria:

Known secondary hypertension

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

400 subjects who are referred for 24hABPM

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ehud Grossman, MD	Contact	972-3-5302834		grosse@post.tau.ac.il

Overall Officials

Name	Affiliation	Role
Ehud Grossman, MD	The Chaim Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chaim Sheba Medical center	Recruiting	Tel Litwinsky	Ramat Gan	52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007024	Hypotension, Orthostatic

Ancestor Terms

ID	Term
D054971	Orthostatic Intolerance
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided