Treatment of Orthostatic Hypotension in SCI

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
James J. Peters Veterans Affairs Medical Center
Study ID
NCT05839652
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hypotension

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2023
Status verified
Sep 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Systolic blood pressure [ Time Frame: 3 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
Matthew T Maher, MS
[email protected]
201-566-0291
James J Peters VA Medical CenterThe BronxNew York10468
Finn E Fox, BS
[email protected]
718-584-9000
Jorge Chavez, BS
[email protected]
718-584-9000
Jill M Wecht, EdD (PRINCIPAL_INVESTIGATOR)

Find similar trials in West Orange, NJ

By research site
Kessler Foundation· West Orange, NJJames J Peters VA Medical Center· The Bronx, NY

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