Treatment of Orthostatic Hypotension in SCI
ConditionHypotension
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorJames J. Peters Veterans Affairs Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
traumatic spinal cord injury
at least 12 months post injury
injury level of C1-T6
AIS A, B or C
Disqualifiers
Active psychiatric disorder
Stroke or cerebrovascular disease
Alzheimer's Disease or dementia
Unmanaged cardiac arrhythmias
Trial design
Design model
Single group
Treatments tested in this trial
Midodrine Hydrochloride
DrugDetermine best drug and dose to increase and stabilize SBP during orthostatic tilt
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Study 1Experimental treatment 1 intervention
Group B: Study 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Systolic blood pressure
determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo
Time frame
3 yearsSecondary outcomes
1
Cerebral blood flow velocity
determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo
Time frame
3 years2
Symptoms of autonomic dysreflexia and orthostatic hypotension
determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
James J. Peters Veterans Affairs Medical Center
Lead sponsor
Kessler Foundation
Collaborator
Source ClinicalTrials.gov