NCT05839652 Treatment of Orthostatic Hypotension in SCI
| NCT ID | NCT05839652 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | James J. Peters Veterans Affairs Medical Center |
| Condition | Hypotension |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 25 participants in total. It began in 2023-07-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.
Eligibility Criteria
Inclusion Criteria: * traumatic spinal cord injury * at least 12 months post injury * injury level of C1-T6 * AIS A, B or C * non-ambulatory * non-ventilator Exclusion Criteria: * Active psychiatric disorder * Stroke or cerebrovascular disease * Alzheimer's Disease or dementia * Unmanaged cardiac arrhythmias * Concurrent systemic, hepatic, or renal disease * Suspected or diagnosed malignancy * Neurological disease other than SCI * Self-reported history of three or more symptomatic episodes of AD per day
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05839652 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05839652 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05839652 currently recruiting?
Yes, NCT05839652 is actively recruiting participants. Contact the research team at matt.maher@va.gov for enrollment information.
Where is the NCT05839652 trial being conducted?
This trial is being conducted at West Orange, United States, The Bronx, United States.
Who is sponsoring the NCT05839652 clinical trial?
NCT05839652 is sponsored by James J. Peters Veterans Affairs Medical Center. The trial plans to enroll 25 participants.