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Trial record 1 of 1 for:    "Dopamine Beta-Hydroxylase Deficiency" | "Nitric Oxide"
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The Pathophysiology of Orthostatic Hypotension

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ClinicalTrials.gov Identifier: NCT00748059
Recruitment Status : Active, not recruiting
First Posted : September 8, 2008
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Emily M. Garland, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE September 5, 2008
First Posted Date  ICMJE September 8, 2008
Last Update Posted Date January 10, 2019
Study Start Date  ICMJE December 1996
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2008)
hemodynamic changes with standing [ Time Frame: following test ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00748059 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2009)
  • blood and urine hormones [ Time Frame: after test ]
  • blood volume [ Time Frame: during supine and/or upright postures ]
  • sympathetic nerve activity [ Time Frame: during stimulation of sympathetic nervous system ]
  • quantitative sweat testing [ Time Frame: 2 hours ]
  • Eye function [ Time Frame: once ]
  • Sleep efficiency [ Time Frame: once ]
  • Metabolic rate [ Time Frame: once ]
  • Pain response [ Time Frame: once ]
  • Responses on questionnaires and computer tasks designed to assess brain function [ Time Frame: once ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2008)
  • blood and urine hormones [ Time Frame: after test ]
  • blood volume [ Time Frame: during supine and/or upright postures ]
  • sympathetic nerve activity [ Time Frame: during stimulation of sympathetic nervous system ]
  • quantitative sweat testing [ Time Frame: 2 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Pathophysiology of Orthostatic Hypotension
Official Title  ICMJE The Pathophysiology of Orthostatic Hypotension
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Autonomic Nervous System Diseases
  • Orthostatic Hypotension
  • Dopamine Beta-Hydroxylase Deficiency
  • Orthostatic Intolerance
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: A
Patients with Orthostatic Hypotension
Interventions:
  • Procedure: Standing or upright tilt
  • Procedure: Microneurography
  • Procedure: QSweat
  • Device: neck cuff stimulation
  • Drug: phenylephrine,isoproterenol,nitroprusside,propranolol,edrophonium,atropine,tyramine
  • Drug: clonidine,yohimbine,metoclopramide,alpha-methyldopa
  • Procedure: BodPod
  • Procedure: Eye exam
  • Procedure: Sleep study
  • Procedure: Pain response testing
  • Procedure: Metabolic chamber
  • Procedure: Brain function studies
  • Procedure: Bicycle Exercise Test
Publications * Arnold AC, Garland EM, Celedonio JE, Raj SR, Abumrad NN, Biaggioni I, Robertson D, Luther JM, Shibao CA. Hyperinsulinemia and Insulin Resistance in Dopamine β-Hydroxylase Deficiency. J Clin Endocrinol Metab. 2017 Jan 1;102(1):10-14. doi: 10.1210/jc.2016-3274.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2008)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00748059
Other Study ID Numbers  ICMJE 030752
HL056693
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emily M. Garland, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emily M Garland, PhD Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP