Recruiting

Orthostatic Hypotension

Sponsor:

James J. Peters Veterans Affairs Medical Center

Code:

NCT05839652

Conditions

Hypotension

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Midodrine Hydrochloride

Study Details

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.

Conditions

Hypotension

Study ID

NCT05839652

Start date

Jul 1, 2023

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study 1

Twenty-five participants will be asked to visit the laboratory on 6 occasions, for an open-label, dose escalation trial to determine the effect of midodrine and droxidopa on supine and seated blood pressure and on symptoms of autonomic dysreflexia and orthostatic hypotension.

experimental: Study 2

Determine the effects of compression garments, midodrine, and droxidopa, compared to placebo, on orthostatic hemodynamics, symptoms of AD and OH and reporting of fatigue and thermal comfort.

Interventions

Midodrine Hydrochloride

Determine best drug and dose to increase and stabilize SBP during orthostatic tilt

Primary outcome measure

  • Systolic blood pressure [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Matt T Maher, MS

9733243588matthew.maher@va.gov

Dylan C Arnero, MA

718-584-9000dylan.arnero@va.gov

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Matthew T Maher, MS

201-566-0291MMaher@Kesslerfoundation.org

James J Peters VA Medical Center

Recruiting

The Bronx, New York, United States, 10468

Contacts

Dylan C Arnero, MA

718-584-9000dylan.arnero@va.gov

Principal Investigator:

Jill M Wecht, EdD

More Information

Sponsor

James J. Peters Veterans Affairs Medical Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by James J. Peters Veterans Affairs Medical Center on 2026-08-10.