NCT00835224

Brief Summary

After a spinal cord injury the brain is no longer completely in control of the body below the level of injury. This affects many organs and systems in the body, we are interested in understanding how a spinal cord injury affects blood pressure and blood flow to the brain. We are going to study blood pressure while the person is seated in a wheelchair before and after we give the subject medications which should increase blood pressure in a laboratory setting and over the course of a normal day in persons with spinal cord injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 23, 2014

Completed
Last Updated

April 23, 2014

Status Verified

March 1, 2014

Enrollment Period

3.1 years

First QC Date

January 30, 2009

Results QC Date

September 12, 2013

Last Update Submit

March 21, 2014

Conditions

Orthostatic HypotensionSpinal Cord Injury

Keywords

Spinal Cord InjuryOrthostatic HypotensionBlood PressureMidodrine HydrochlorideL-NAME

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration

Study Arms (3)

Midodrine

EXPERIMENTAL

A drug to treat low blood pressure.

Drug: Midodrine

L-Name

EXPERIMENTAL

L-Name: A non-selective inhibitor of nitric oxide synthase and placebo. It has been used experimentally to induce hypertension.

Drug: L-NAME

Placebo

PLACEBO COMPARATOR

Placebo: A pill with an inactive substance that looks like the study drug.

Drug: Placebo

Interventions

L-NAMEDRUG

A non-selective inhibitor of nitric oxide synthase and placebo. It has been used experimentally to induce hypertension.

L-Name
MidodrineDRUG

To treat low blood pressure.

Midodrine
PlaceboDRUG

A pill with an inactive substance that looks like the study drug.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal Cord Injured Subjects:
  • chronic spinal cord injury (1 year post injury) with a seated MAP of 65mmHg (almost all individuals with tetraplegia demonstrate this)
  • Male or female with an age of 18 - 65 years
  • Control Subjects:
  • Male or female with an age of 18 - 65 years

You may not qualify if:

  • Spinal Cord Injured Subjects:
  • acute illness
  • cardiovascular disease
  • renal disease
  • medications that affect the cardiovascular system
  • Control Subjects:
  • acute illness
  • cardiovascular disease
  • renal disease
  • medications that affect the cardiovascular system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Related Publications (1)

  • Wecht JM, Radulovic M, Rosado-Rivera D, Zhang RL, LaFountaine MF, Bauman WA. Orthostatic effects of midodrine versus L-NAME on cerebral blood flow and the renin-angiotensin-aldosterone system in tetraplegia. Arch Phys Med Rehabil. 2011 Nov;92(11):1789-95. doi: 10.1016/j.apmr.2011.03.022. Epub 2011 Jul 16.

    PMID: 21762873RESULT

MeSH Terms

Conditions

Hypotension, OrthostaticSpinal Cord Injuries

Interventions

NG-Nitroarginine Methyl EsterMidodrine

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

ArginineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Limitations and Caveats

Study population was relatively small and were not blinded to the interventions.

Results Point of Contact

Title
Dr. Jill M. Wecht
Organization
James J Peters VAMC
jm.wecht@va.gov
718 584-9000

Study Officials

  • Jill Wecht, EdD

    VA Medical Center, Bronx

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2009

First Posted

February 3, 2009

Study Start

May 1, 2010

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

April 23, 2014

Results First Posted

April 23, 2014

Record last verified: 2014-03

Locations

US(1)