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Treatment of Orthostatic Hypotension in SCI

Sponsor
James J. Peters Veterans Affairs Medical Center (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05839652
Collaborator
Kessler Foundation (Other)
25
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Midodrine Hydrochloride
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2026
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

Arm Intervention/Treatment
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.

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

    		•
    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.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Systolic blood pressure [3 years]

      determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo

    Secondary Outcome Measures

    1. Cerebral blood flow velocity [3 years]

      determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo

    2. Symptoms of autonomic dysreflexia and orthostatic hypotension [3 years]

      determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • James J. Peters Veterans Affairs Medical Center
    • Kessler Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jill M. Wecht, Ed.D., Research Scientist, James J. Peters Veterans Affairs Medical Center
    ClinicalTrials.gov Identifier:
    NCT05839652
    Other Study ID Numbers:
    • 1747301-1
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Hypotension, Orthostatic
    Hypotension
    Midodrine
    Droxidopa

    Study Results

    No Results Posted as of May 3, 2023