Hypotension, Orthostatic HypotensionOHNCT02123303
Orthostatic Hypotension Among Veterans
An observational study of Hypotension, Orthostatic Hypotension, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
Orthostatic hypotension (OH) is defined as a fall in blood pressure when standing. Several different underlying diseases, conditions, or combinations of medicines may contribute to OH; therefore the cause of the condition varies among individuals. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Orthostatic Hypotension
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jul 2015
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any able-bodied veteran (able to independently stand for 10 minutes) that presents for a routine clinical visit or a neurological clinic visit at the James J. Peters VA Medical Center and does not have an acute illness or infection is eligible to participate in the study.
Who may be able to join
- Veterans
- Between the ages of 18 and 89
Who cannot join
- Current illness/infection
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence of Orthostatic Hypotension Among Veterans
Orthostatic hypotension (OH) is defined as a fall in blood pressure when standing. Several different underlying diseases, conditions, or combinations of medicines may contribute to OH; therefore the cause of the condition varies among individuals. Some studies have shown that OH is associated with an increase in the rate of death, but it is not clear what role OH plays in increased morbidity. By studying what the prevalence of OH is in a generalized veteran population we expect increase clinical awareness of the degree of the problem so that patient care might be improved.
- Conditions
- Hypotension, Orthostatic Hypotension
- Keywords
- Hypotension, Orthostatic Hypotension
- Medical subject headings
- Hypotension, Orthostatic
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 |
|---|---|---|
| Veterans | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure from supine to standing.
Change in blood pressure between Evaluation #1 and Evaluation #2.
Measured: Eval#1: 10min supine; Eval#2: 10min standing;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startNov 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension, Orthostatic HypotensionStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Jill M Wecht, EdD, Principal investigator, James J. Peters VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123303
- Sponsor's protocol ID
- WEC-10-038
- Acronym
- OH
- Status last verified
- Feb 2019
- First submitted
- 23 Apr 2014
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Orthostatic Hypotension Among Veterans
- ClinicalTrials.gov ID
- NCT02123303
- Acronym / sponsor ID
- OH / WEC-10-038
- Conditions
- Hypotension, Orthostatic Hypotension
- Keywords
- Hypotension, Orthostatic Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- Nov 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Apr 2014 (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.
Orthostatic hypotension (OH) is defined as a fall in blood pressure when standing. Several different underlying diseases, conditions, or combinations of medicines may contribute to OH; therefore the cause of the condition varies among individuals. Some studies have shown that OH is associated with an increase in the rate of death, but it is not clear what role OH plays in increased morbidity. By studying what the prevalence of OH is in a generalized veteran population we expect increase clinical awareness of the degree of the problem so that patient care might be improved.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veterans | – | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any able-bodied veteran (able to independently stand for 10 minutes) that presents for a routine clinical visit or a neurological clinic visit at the James J. Peters VA Medical Center and does not have an acute illness or infection is eligible to participate in the study.
Key inclusion criteria (2 listed)
- Veterans
- Between the ages of 18 and 89
Key exclusion criteria (2 listed)
- Current illness/infection
- Pregnant
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
Change in blood pressure from supine to standing.
Time frame: Eval#1: 10min supine; Eval#2: 10min standing;
Change in blood pressure between Evaluation #1 and Evaluation #2.
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 1 Mar 2019.
Related trials for Hypotension, Orthostatic Hypotension
Active, not recruitingPhase 2
A Study in Subjects With Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
Active, not recruiting
Water and the Gastropressor Response - Diurnal Variability
Orthostatic Hypotension
Active, not recruiting
Water and the Gastropressor Response - Tachyphylaxis
Orthostatic Hypotension
Not yet recruiting
Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
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.
Jill M Wecht, EdD principal investigator
James J. Peters VAMC
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 Hypotension, Orthostatic Hypotension, run by James J. Peters Veterans Affairs Medical Center 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 2 inclusion and 2 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 1 Mar 2019. 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?
Change in blood pressure from supine to standing. (time frame: Eval#1: 10min supine; Eval#2: 10min standing;). 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 1 Mar 2019.