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The Pathophysiology of Orthostatic Hypotension

Primary Purpose

Autonomic Nervous System Diseases, Orthostatic Hypotension, Dopamine Beta-Hydroxylase Deficiency

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Standing or upright tilt
Microneurography
QSweat
neck cuff stimulation
phenylephrine,isoproterenol,nitroprusside,propranolol,edrophonium,atropine,tyramine
clonidine,yohimbine,metoclopramide,alpha-methyldopa
BodPod
Eye exam
Sleep study
Pain response testing
Metabolic chamber
Brain function studies
Bicycle Exercise Test
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Autonomic Nervous System Diseases focused on measuring autonomic nervous system diseases, blood pressure, congenital, orthostasis, catecholamines

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • severe orthostatic hypotension and other autonomic symptoms but do not meet criteria for standard diagnosis
  • non-smokers
  • drug-free
  • able to give informed consent
  • free of pulmonary, renal, hematopoietic, hepatic and cardiac disease

Exclusion Criteria:

  • medications affecting the autonomic nervous system
  • any chronic illness
  • anemia (Hct<30)
  • women of childbearing age who are pregnant or nursing
  • smokers

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Patients with Orthostatic Hypotension

Outcomes

Primary Outcome Measures

hemodynamic changes with standing

Secondary Outcome Measures

blood and urine hormones
blood volume
sympathetic nerve activity
quantitative sweat testing
Eye function
Sleep efficiency
Metabolic rate
Pain response
Responses on questionnaires and computer tasks designed to assess brain function

Full Information

First Posted
September 5, 2008
Last Updated
May 7, 2021
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00748059
Brief Title
The Pathophysiology of Orthostatic Hypotension
Official Title
The Pathophysiology of Orthostatic Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the cause of low blood pressure in selective patients who have problems with their involuntary (autonomic) nervous system. These patients frequently have had symptoms throughout their life, and their disorder might have a genetic basis. The biochemical, physiological and pharmacological procedures in this study should help us define the problem and perhaps lead to more effective treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Nervous System Diseases, Orthostatic Hypotension, Dopamine Beta-Hydroxylase Deficiency, Orthostatic Intolerance
Keywords
autonomic nervous system diseases, blood pressure, congenital, orthostasis, catecholamines

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Patients with Orthostatic Hypotension
Intervention Type
Procedure
Intervention Name(s)
Standing or upright tilt
Intervention Description
stand upright or tilt table test
Intervention Type
Procedure
Intervention Name(s)
Microneurography
Intervention Description
Recording from sympathetic nerve
Intervention Type
Procedure
Intervention Name(s)
QSweat
Intervention Description
quantitative sweat testing
Intervention Type
Device
Intervention Name(s)
neck cuff stimulation
Intervention Description
Blood pressure receptors in the neck arteries may be stimulated by applying suction through a collar around the neck.
Intervention Type
Drug
Intervention Name(s)
phenylephrine,isoproterenol,nitroprusside,propranolol,edrophonium,atropine,tyramine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
clonidine,yohimbine,metoclopramide,alpha-methyldopa
Intervention Description
Oral Pharmacological Testing clonidine 0.1-0.3 mg, yohimbine 5-10 mg, metoclopramide 10 mg, alpha-methyldopa 62.5 mg, placebo
Intervention Type
Procedure
Intervention Name(s)
BodPod
Intervention Description
Determination of body composition
Intervention Type
Procedure
Intervention Name(s)
Eye exam
Intervention Description
Examination of pressure in the eye and eyelid fatiguability. The following eyedrops might be used: 0.5% proparacaine (Alcaine, Allergan, Inc) Fluress (0.4% benoxinate hydrochloride, fluorescein sodium, Akorn, Inc) 0.5%, 1% tropicamide (Mydriacyl, Alcon) Over-the-counter preservative-free artificial tears 0.25%, 2.5% and 10% phenylephrine (Bausch and Lomb) 1% cyclopentolate hydrochloride (Alcon)
Intervention Type
Procedure
Intervention Name(s)
Sleep study
Intervention Description
Recording of sleep pattern overnight
Intervention Type
Procedure
Intervention Name(s)
Pain response testing
Intervention Description
Subjects will rate the quality and intensity of 2 pain tasks.
Intervention Type
Procedure
Intervention Name(s)
Metabolic chamber
Intervention Description
Determination of metabolic rate via 24hr stay in whole-room indirect calorimeter
Intervention Type
Procedure
Intervention Name(s)
Brain function studies
Intervention Description
Questionnaires and computer tasks, an EEG and an MRI may be used to assess brain function.
Intervention Type
Procedure
Intervention Name(s)
Bicycle Exercise Test
Intervention Description
Blood pressure and heart rate may be monitored while exercising on a stationary bicycle.
Primary Outcome Measure Information:
Title
hemodynamic changes with standing
Time Frame
following test
Secondary Outcome Measure Information:
Title
blood and urine hormones
Time Frame
after test
Title
blood volume
Time Frame
during supine and/or upright postures
Title
sympathetic nerve activity
Time Frame
during stimulation of sympathetic nervous system
Title
quantitative sweat testing
Time Frame
2 hours
Title
Eye function
Time Frame
once
Title
Sleep efficiency
Time Frame
once
Title
Metabolic rate
Time Frame
once
Title
Pain response
Time Frame
once
Title
Responses on questionnaires and computer tasks designed to assess brain function
Time Frame
once

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: severe orthostatic hypotension and other autonomic symptoms but do not meet criteria for standard diagnosis non-smokers drug-free able to give informed consent free of pulmonary, renal, hematopoietic, hepatic and cardiac disease Exclusion Criteria: medications affecting the autonomic nervous system any chronic illness anemia (Hct<30) women of childbearing age who are pregnant or nursing smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily M Garland, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27778639
Citation
Arnold AC, Garland EM, Celedonio JE, Raj SR, Abumrad NN, Biaggioni I, Robertson D, Luther JM, Shibao CA. Hyperinsulinemia and Insulin Resistance in Dopamine beta-Hydroxylase Deficiency. J Clin Endocrinol Metab. 2017 Jan 1;102(1):10-14. doi: 10.1210/jc.2016-3274.
Results Reference
derived

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The Pathophysiology of Orthostatic Hypotension

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