← Back to Search

Alpha-1 Agonist

BP Threshold Treatment Group for Low Blood Pressure

Phase 2 & 3
Waitlist Available
Led By Jill M Wecht, Ed.D.
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

While treatment strategies for OH have been identified for use in persons with acute SCI, the field of SCI medicine lacks a gold standard for treatment thresholds and well-defined outcome parameters. Comprehensively documenting the impact of orthostatic hypotension (OH), regardless of symptoms, during acute rehabilitation and identifying the effects of two different treatment approaches on therapy participation and adherence to an intended rehabilitation plan could have a significant impact on clinical practice in the acute rehabilitation setting following SCI.

Eligible Conditions
  • Autonomic Dysfunction
  • Vagal Integrity
  • Baroreceptor Integrity
  • Low Blood Pressure
  • Cerebral Blood Flow
  • High Blood Pressure
  • Venous Occlusion Plethysmography
  • Orthostatic Hypotension
  • Autonomic Dysreflexia
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rehabilitation
Systolic Blood Pressure
Secondary outcome measures
Cerebral Blood Flow
Orthostatic Hypotension and Autonomic Dysreflexia

Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual Care GroupExperimental Treatment1 Intervention
Individuals randomized to the usual care group will receive BP management according to the usual care in current practice in the SCI Rehabilitation Unit. Will receive treatment only if they experience symptoms that are associated with low BP (dizziness, lightheadedness, nausea, blurry vision, loss of consciousness, etc.). Treatment to lessen or eliminate these symptoms of low blood pressure will be guided by the attending physician and can include physical countermeasures to increase blood pressure (abdominal binders, comperssion stockings, etc.) and/or midodrine .
Group II: BP Threshold Treatment GroupExperimental Treatment1 Intervention
Individuals assigned to the BP threshold treatment group will receive BP management, regardless of symptoms, to maintain systolic BP between 111-135 mmHg for males and 101-135 mmHg for females for the duration of their in-patient hospital stay. This treatment will be started based on your low BP, regardless of if you experience symptoms that are associated with low BP (dizziness, lightheadedness, nausea, blurry vision, loss of consciousness, etc.). Before you start on any medication you will receive physical countermeasures to increase blood pressure (abdominal binders, comperssion stockings, etc.). If your blood pressure remains low after using these countermeasures you will begin to take midodrine 3 times a day as described in the intervention section. The dosage will increase and be stopped once until your seated SBP is between 111-135 mmHg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midodrine
FDA approved

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,834 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
886 Previous Clinical Trials
534,977 Total Patients Enrolled
Jill M Wecht, Ed.D.Principal InvestigatorJames J. Peters VA Medical Center
3 Previous Clinical Trials
248 Total Patients Enrolled
~8 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top