Orthostatic HypotensionNCT00248807
A Study of Blood Pressure and Blood Supply to the Brain in Persons With a Spinal Cord Injury.
A study testing 1.25 mg enalaprilat IV and Head up tilt (HUT) in people with Orthostatic Hypotension and Spinal Cord Injuries, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to determine how blood pressure and blood flow are controlled during head-up tilt in a semi-upright position. In this investigation we are studying blood pressure and blood flow to the brain, with and without a medication which lowers blood pressure (Vasotec). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthostatic Hypotension, Spinal Cord Injuries
- What is being tested?
- 1.25 mg enalaprilat IV and Head up tilt (HUT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Duration of spinal cord injury (SCI) at least 1 year
- Level of SCI C4-8 and T6 and below
- matched non-SCI subjects
- Chronological age between 18-65 years
- Euhydration: Subjects will be instructed to avoid caffeine and alcohol and to maintain normal salt and water intake for several days prior to study.
Who cannot join
- Known heart and/or blood vessel disease
- Dehydration
- High blood pressure
- Kidney disease
- Diabetes mellitus
- Prescribed ACE inhibitors
Show all 9Show fewer
- Acute Infection
- Smoking
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Hemodynamics and Cerebral Blood Flow in Persons With Tetraplegia
The purpose of this study is to determine how blood pressure and blood flow are controlled during head-up tilt in a semi-upright position. In this investigation we are studying blood pressure and blood flow to the brain, with and without a medication which lowers blood pressure (Vasotec). We will determine how persons with a spinal cord injury are able to maintain blood flow to the brain (not get dizzy) as they assume a more upright position and their blood pressure decreases.
Read the detailed description
Individuals with tetraplegia lack normal sympathetic nervous system regulation of blood pressure and, therefore, relative hypotension is a common occurrence. This hypotension may be more pronounced with postural stress. Loss in mental acuity and sometimes even consciousness is an associated symptom of postural hypotension in individuals with tetraplegia.
There is some evidence to suggest that although mean arterial blood pressure (MAP) is relatively low in these individuals, middle cerebral arterial blood flow (CBF) may be maintained. Consequently, individuals with chronic tetraplegia often compensate and are stable in the seated upright position.
Autoregulation of CBF has been defined as the stability of cerebral blood flow throughout a range of systemic blood pressures (MAP). This proposal will examine systemic hemodynamics and middle cerebral artery blood flow during HUT with and without Vasotec, an angiotensin II inhibitor. By partially or completely ablating the renin-angiotensin system, which is postulated to play a major role in blood pressure regulation, the potential dissociation between systemic blood pressure and middle cerebral artery blood flow, in individuals with tetraplegia, may be demonstrated. The aim is to determine whether persons with chronic tetraplegia are able to maintain similar CBF, or similar CBF changes, as able-bodied controls despite a greater decrease in MAP to the same hypotensive challenge. The relationship between MAP and CBF has not been defined in this population. Understanding this relationship may lead to improved screening and treatment for prevention of postural hypotension in persons with tetraplegia.
- Conditions
- Orthostatic Hypotension, Spinal Cord Injuries
- Being tested
- 1.25 mg enalaprilat IV, Head up tilt (HUT)
- Keywords
- Blood Pressure, Low, Hypotension, Postural, Injuries, Spinal Cord, Spinal Cord Transection, Spinal Cord Trauma
- Medical subject headings
- Hypotension, Orthostatic, Spinal Cord Injuries, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.25 mg enalaprilat IVDrug
an angiotensin converting enzyme (ACE) inhibitor given to lower blood pressure (BP) and measure cerebral blood flow (CBF)
Head up tilt (HUT)Other
45 degree head-up tilt to lower blood pressure and measure cerebral blood flow.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Placebo comparator | Head-up tilt maneuver without drug in subjects with spinal cord injury Receives: Other: Head up tilt (HUT) |
| ARM 3 | Placebo comparator | Head-up tilt maneuver without drug in able-bodied controls Receives: Other: Head up tilt (HUT) |
| ARM 2 | Active comparator | Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in subjects with spinal cord injury Receives: Drug: 1.25 mg enalaprilat IV; Other: Head up tilt (HUT) |
| ARM 4 | Active comparator | Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in able-bodied controls. Receives: Drug: 1.25 mg enalaprilat IV; Other: Head up tilt (HUT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention
Measured: acute testing
Secondary outcomes (1)
Cerebral Blood Flow
Measurement of middle cerebral artery blood flow velocity supine and during head-up tilt
Measured: acute testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionMay 2009
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jill Wecht, EdD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248807
- Sponsor's protocol ID
- B3346-V
- Other IDs
- 00517
- Status last verified
- Feb 2025
- First submitted
- 2 Nov 2005
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Handrakis JP, DeMeersman RE, Rosado-Rivera D, LaFountaine MF, Spungen AM, Bauman WA, Wecht JM. Effect of hypotensive challenge on systemic hemodynamics and cerebral blood flow in persons with tetraplegia. Clin Auton Res. 2009 Feb;19(1):39-45. doi: 10.1007/s10286-008-0496-6. Epub 2008 Oct 11.
PubMed 18850311
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Hemodynamics and Cerebral Blood Flow in Persons With Tetraplegia
- ClinicalTrials.gov ID
- NCT00248807
- Acronym / sponsor ID
- B3346-V
- Conditions
- Orthostatic Hypotension, Spinal Cord Injuries
- Keywords
- Blood Pressure, Low, Hypotension, Postural, Injuries, Spinal Cord, Spinal Cord Transection, Spinal Cord Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 4 Nov 2005 (estimated)
- Results
- Posted 23 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how blood pressure and blood flow are controlled during head-up tilt in a semi-upright position. In this investigation we are studying blood pressure and blood flow to the brain, with and without a medication which lowers blood pressure (Vasotec). We will determine how persons with a spinal cord injury are able to maintain blood flow to the brain (not get dizzy) as they assume a more upright position and their blood pressure decreases.
Detailed description
Individuals with tetraplegia lack normal sympathetic nervous system regulation of blood pressure and, therefore, relative hypotension is a common occurrence. This hypotension may be more pronounced with postural stress. Loss in mental acuity and sometimes even consciousness is an associated symptom of postural hypotension in individuals with tetraplegia.
There is some evidence to suggest that although mean arterial blood pressure (MAP) is relatively low in these individuals, middle cerebral arterial blood flow (CBF) may be maintained. Consequently, individuals with chronic tetraplegia often compensate and are stable in the seated upright position.
Autoregulation of CBF has been defined as the stability of cerebral blood flow throughout a range of systemic blood pressures (MAP). This proposal will examine systemic hemodynamics and middle cerebral artery blood flow during HUT with and without Vasotec, an angiotensin II inhibitor. By partially or completely ablating the renin-angiotensin system, which is postulated to play a major role in blood pressure regulation, the potential dissociation between systemic blood pressure and middle cerebral artery blood flow, in individuals with tetraplegia, may be demonstrated. The aim is to determine whether persons with chronic tetraplegia are able to maintain similar CBF, or similar CBF changes, as able-bodied controls despite a greater decrease in MAP to the same hypotensive challenge. The relationship between MAP and CBF has not been defined in this population. Understanding this relationship may lead to improved screening and treatment for prevention of postural hypotension in persons with tetraplegia.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Placebo comparator | Other: Head up tilt (HUT)Head-up tilt maneuver without drug in subjects with spinal cord injury |
| ARM 3 | Placebo comparator | Other: Head up tilt (HUT)Head-up tilt maneuver without drug in able-bodied controls |
| ARM 2 | Active comparator | Drug: 1.25 mg enalaprilat IV, Other: Head up tilt (HUT)Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in subjects with spinal cord injury |
| ARM 4 | Active comparator | Drug: 1.25 mg enalaprilat IV, Other: Head up tilt (HUT)Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in able-bodied controls. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Duration of spinal cord injury (SCI) at least 1 year
- Level of SCI C4-8 and T6 and below
- matched non-SCI subjects
- Chronological age between 18-65 years
- Euhydration: Subjects will be instructed to avoid caffeine and alcohol and to maintain normal salt and water intake for several days prior to study.
Key exclusion criteria (9 listed)
- Known heart and/or blood vessel disease
- Dehydration
- High blood pressure
- Kidney disease
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.25 mg enalaprilat IVan angiotensin converting enzyme (ACE) inhibitor given to lower blood pressure (BP) and measure cerebral blood flow (CBF) | Drug | ARM 2, ARM 4 |
| Head up tilt (HUT)45 degree head-up tilt to lower blood pressure and measure cerebral blood flow. | Other | ARM 1, ARM 2, ARM 3, ARM 4 |
Primary outcome
Systolic Blood Pressure
Time frame: acute testing
Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention
1 secondary outcome
Cerebral Blood Flow
Time frame: acute testing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18850311Handrakis JP, DeMeersman RE, Rosado-Rivera D, LaFountaine MF, Spungen AM, Bauman WA, Wecht JM. Effect of hypotensive challenge on systemic hemodynamics and cerebral blood flow in persons with tetraplegia. Clin Auton Res. 2009 Feb;19(1):39-45. doi: 10.1007/s10286-008-0496-6. Epub 2008 Oct 11.
Related trials for 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 - Tachyphylaxis
Orthostatic Hypotension
Active, not recruiting
Water and the Gastropressor Response - Diurnal Variability
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 Wecht, EdD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.25 mg enalaprilat IV and Head up tilt (HUT) in people with Orthostatic Hypotension and Spinal Cord Injuries, run by VA Office of Research and Development 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 5 inclusion and 9 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 25 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Systolic Blood Pressure (time frame: acute testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00248807, which also lists 1 linked publication.
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 25 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.