Orthostatic ToleranceNCT00844181
Racial Differences in Orthostatic Tolerance
An observational study of Orthostatic Tolerance, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Orthostatic Tolerance
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Community sample of women of reproductive age
Who may be able to join
- women between 18-25 yrs of age
Who cannot join
- history of high blood pressure, uterine fibroids, diabetes, epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
John B. Pierce Laboratory
New Haven, Connecticut, 06519
About this study
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).
- Conditions
- Orthostatic Tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 0 | white women | |
| 1 | Black women |
What is being measured
The primary outcome is the main question the study is designed to answer.
orthostatic tolerance
Measured: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startOct 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic ToleranceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Nina Stachenfeld, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844181
- Sponsor's protocol ID
- 0512000875
- Other IDs
- 3R01HL071159-04A1S1
- Status last verified
- Feb 2009
- First submitted
- 13 Feb 2009
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Differences in Orthostatic Tolerance
- ClinicalTrials.gov ID
- NCT00844181
- Acronym / sponsor ID
- 0512000875
- Conditions
- Orthostatic Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0 | – | –white women |
| 1 | – | –Black women |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample of women of reproductive age
Key inclusion criteria (1 listed)
- women between 18-25 yrs of age
Key exclusion criteria (1 listed)
- history of high blood pressure, uterine fibroids, diabetes, epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
orthostatic tolerance
Time frame: 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2009.
Related trials for Orthostatic Tolerance
Active, not recruiting
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
Postural Tachycardia Syndrome
Recruiting
Hypercapnia and Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome
Postural Tachycardia Syndrome, Orthostatic Intolerance
Recruiting
The Effect of Water Carbonation on Orthostatic Tolerance
Orthostatic Hypotension, Syncope
Active, not recruiting
Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)
Postural Tachycardia Syndrome, Postural Orthostatic Tachycardia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Stachenfeld, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthostatic Tolerance, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
orthostatic tolerance (time frame: 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2009.