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Recruiting NCT05839652

Treatment of Orthostatic Hypotension in SCI

Phase IV Interventional Hypotension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Midodrine Hydrochloride.
Who it may be relevant to
Registry conditions: Hypotension. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury

Overview

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.

Interventions

  • Drug Midodrine Hydrochloride
    Determine best drug and dose to increase and stabilize SBP during orthostatic tilt

Primary outcome measures

  • Systolic blood pressure [Time frame: 3 years]
Secondary outcome measures (2)
  • Cerebral blood flow velocity [Time frame: 3 years]
  • Symptoms of autonomic dysreflexia and orthostatic hypotension [Time frame: 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Kessler Foundation — West Orange
  • James J Peters VA Medical Center — The Bronx

Identifiers

NCT: NCT05839652 · 1747301-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗