The Pathophysiology of Orthostatic Hypotension

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 31, 1996

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2020

Conditions
Autonomic Nervous System DiseasesOrthostatic HypotensionDopamine Beta-Hydroxylase DeficiencyOrthostatic Intolerance
Interventions
PROCEDURE

Standing or upright tilt

stand upright or tilt table test

PROCEDURE

Microneurography

Recording from sympathetic nerve

PROCEDURE

QSweat

quantitative sweat testing

DEVICE

neck cuff stimulation

Blood pressure receptors in the neck arteries may be stimulated by applying suction through a collar around the neck.

DRUG

phenylephrine,isoproterenol,nitroprusside,propranolol,edrophonium,atropine,tyramine

"IV Pharmacological Testing~phenylephrine 12.5 - 400 ug, isoproterenol 0.1 - 0.4 ug or higher until desired effect, nitroprusside 0.1 - 1.6 ug/kg, propranolol 1.1 mg/min, edrophonium maximum of 10 mg, atropine .01 mg/kg, tyramine 250-4000 ug or higher until desired effect"

DRUG

clonidine,yohimbine,metoclopramide,alpha-methyldopa

"Oral Pharmacological Testing~clonidine 0.1-0.3 mg, yohimbine 5-10 mg, metoclopramide 10 mg, alpha-methyldopa 62.5 mg, placebo"

PROCEDURE

BodPod

Determination of body composition

PROCEDURE

Eye exam

"Examination of pressure in the eye and eyelid fatiguability. The following eyedrops might be used:~1. 0.5% proparacaine (Alcaine, Allergan, Inc)~2. Fluress (0.4% benoxinate hydrochloride, fluorescein sodium, Akorn, Inc)~3. 0.5%, 1% tropicamide (Mydriacyl, Alcon)~4. Over-the-counter preservative-free artificial tears~5. 0.25%, 2.5% and 10% phenylephrine (Bausch and Lomb)~6. 1% cyclopentolate hydrochloride (Alcon)"

PROCEDURE

Sleep study

Recording of sleep pattern overnight

PROCEDURE

Pain response testing

Subjects will rate the quality and intensity of 2 pain tasks.

PROCEDURE

Metabolic chamber

Determination of metabolic rate via 24hr stay in whole-room indirect calorimeter

PROCEDURE

Brain function studies

Questionnaires and computer tasks, an EEG and an MRI may be used to assess brain function.

PROCEDURE

Bicycle Exercise Test

Blood pressure and heart rate may be monitored while exercising on a stationary bicycle.

Trial Locations (1)

37232

Vanderbilt University, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER

NCT00748059 - The Pathophysiology of Orthostatic Hypotension | Biotech Hunter | Biotech Hunter