Racial Differences in Orthostatic Tolerance | NCT00844181

Studies
Racial Differences in Orthostatic Tolerance

NCT00844181

Sponsor

Yale University

Status

Completed

Last Update Posted

Feb 16, 2009Estimated

Enrollment

18Actual

Phase

Not provided

Conditions

Orthostatic Tolerance

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
3R01HL071159-04A1S1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Feb 13, 2009

First Submission Date that Met QC Criteria

Feb 13, 2009

First Posted Date

Feb 16, 2009Estimated

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

Feb 13, 2009

Last Update Posted Date

Feb 16, 2009Estimated

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

Our central hypothesis is that baroreflex sensitivity is attenuated in black women compared to white women, and that this dysregulation will be apparent during orthostatic challenges. We expect that the cumulative stress index (CSI), a measure of maximal orthostatic tolerance, is higher in Black women (BW) compared to White women (WW).

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

Retention

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0		white women
1		Black women

Interventions

Not provided

Measure	Description	Time Frame
orthostatic tolerance		1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women between 18-25 yrs of age

Exclusion Criteria:

history of high blood pressure, uterine fibroids, diabetes, epilepsy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Community sample of women of reproductive age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nina Stachenfeld, PhD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
John B. Pierce Laboratory		New Haven	Connecticut	06519	United States