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Treatment of Orthostatic Hypotension in SCI (SCI)

Primary Purpose

Hypotension

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Midodrine Hydrochloride
Sponsored by
James J. Peters Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Study 1

    Study 2

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Cerebral blood flow velocity
    determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo
    Symptoms of autonomic dysreflexia and orthostatic hypotension
    determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo

    Full Information

    First Posted
    April 20, 2023
    Last Updated
    April 20, 2023
    Sponsor
    James J. Peters Veterans Affairs Medical Center
    Collaborators
    Kessler Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05839652
    Brief Title
    Treatment of Orthostatic Hypotension in SCI
    Acronym
    SCI
    Official Title
    Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2026 (Anticipated)
    Study Completion Date
    June 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    James J. Peters Veterans Affairs Medical Center
    Collaborators
    Kessler Foundation

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study 1
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Study 2
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Midodrine Hydrochloride
    Other Intervention Name(s)
    Droxidopa
    Intervention Description
    Determine best drug and dose to increase and stabilize SBP during orthostatic tilt
    Primary Outcome Measure Information:
    Title
    Systolic blood pressure
    Description
    determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Cerebral blood flow velocity
    Description
    determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo
    Time Frame
    3 years
    Title
    Symptoms of autonomic dysreflexia and orthostatic hypotension
    Description
    determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Matt G. Maher, MS
    Phone
    9733243588
    Email
    matt.maher@va.gov

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Treatment of Orthostatic Hypotension in SCI

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