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Treatment of Orthostatic Hypotension in Autonomic Failure

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ClinicalTrials.gov Identifier: NCT00223691
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University

Study Description
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Brief Summary:
The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.

Condition or disease Intervention/treatment Phase
Autonomic Failure Orthostatic Hypotension Drug: Atomoxetine Drug: Acarbose Drug: Pyridostigmine Bromide Drug: Yohimbine Drug: Midodrine HCl Drug: placebo Drug: Modafinil Drug: Octreotide Other: water intake Drug: Diphenhydramine Hydrochloride Drug: Ranitidine HCL Drug: Tranylcypromine Drug: Ergotamine/ Caffeine Drug: Celecoxib Drug: Pseudoephedrine Drug: Methylphenidate Drug: Indomethacin Drug: Ibuprofen Drug: Oxymetazoline 0.05% nasal solution Dietary Supplement: Bovril Drug: Acetazolamide Drug: Rivastigmine tartrate Drug: Carbidopa/levodopa Device: Inflatable abdominal binder Device: inflatable abdominal binder (sham) Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 389 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Evaluation and Treatment of Autonomic Failure.
Study Start Date : March 2002
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1: active intervention
atomoxetine, pyridostigmine bromide, yohimbine, midodrine hcl, modafinil, octreotide, water intake, ranitidine hcl, diphenhydramine hydrochloride, tranylcypromine, ergotamine/ caffeine, celecoxib, pseudoephedrine, methylphenidate, indomethacin, ibuprofen, Oxymetazoline 0.05% nasal solution, acarbose, Rivastigmine tartrate, acetazolamide, carbidopa/levodopa, inflatable abdominal binder or bovril
 Drug: Atomoxetine
10-50 mg, PO. Single dose. Alone or in combination with Yohimbine or Mestinon.
Other Name: Strattera

Drug: Acarbose
25-100 mg, PO. Single dose.
Other Name: Precose

Drug: Pyridostigmine Bromide
30 mg-180 mg PO. Single dose. Alone or in combination with Yohimbine or atomoxetine.
Other Name: Mestinon

Drug: Yohimbine
2.7, 5.4 or 10.8 mg PO. Single dose. Alone or in combination with Atomoxetine or Pyridostigmine.
Other Name: Yocon

Drug: Midodrine HCl
2.5, 5.0, 7.5, 10 mg PO. Single dose
Other Name: ProAmatine

Drug: Modafinil
50-400 mg PO. Single dose
Other Name: Provigil

Drug: Octreotide
5-50 µg, S.C. Single dose.
Other Name: Sandostatin

Other: water intake
Tap water 2 onz., 8 oz., 16 oz. PO, alone or in combination with any of the above medications. Single dose.

Drug: Diphenhydramine Hydrochloride
12.5 mg-100 mg PO. Single dose. Alone or in combination with Ranitidine
Other Name: Benadryl

Drug: Ranitidine HCL
150-300 mg PO. Single dose. Alone or in combination with Diphenhydramine.
Other Name: zantac

Drug: Tranylcypromine
5 - 40 mg PO. Single dose
Other Name: Parnate

Drug: Ergotamine/ Caffeine
Ergotamine: 1.0 mg PO. Single dose. Caffeine 100 mg PO.Single dose
Other Name: Cafergot

Drug: Celecoxib
50-200 mg PO. Single dose
Other Name: Celebrex

Drug: Pseudoephedrine
15, 30 or 60 mg, PO. Single dose.
Other Name: Sudafed

Drug: Methylphenidate
5 or 10 mg PO. Single dose.
Other Name: Ritalin

Drug: Indomethacin
25, 50 or 75 mg, PO. Singe dose.
Other Name: Indocin

Drug: Ibuprofen
300, 600 or 900 mg, PO. Single dose.
Other Name: Advil, Motrin

Drug: Oxymetazoline 0.05% nasal solution
1-2 sprays/ nostril. Single dose.
Other Name: Afrin

Dietary Supplement: Bovril
6-10 g, PO. Single dose.

Drug: Acetazolamide
125-1000 mg PO. Single dose. Alone or in combination with yohimbine or midodrine
Other Name: Diamox

Drug: Rivastigmine tartrate
1.5-6 mg PO. Single dose.
Other Name: Exelon

Drug: Carbidopa/levodopa
10mg/100mg or 25mg/100mg. 1-2 tab PO. Single dose. Alone or in combination with carbidopa (Lodosyn) 25-175 mg
Other Name: Sinemet, Lodosyn

Device: Inflatable abdominal binder
External abdominal compression (20-40 mm Hg) with an inflatable abdominal binder applied after a pressor agent (e.g. midodrine, yohimbine).
Other Name: external abdominal compression
Placebo Comparator: 2: Placebo or sham device
placebo pill or inflatable abdominal binder (sham)
 Drug: placebo
PO.Single dose.

Device: inflatable abdominal binder (sham)
External abdominal compression (5 mm Hg) with an inflatable abdominal binder applied after a pressor agent (e.g. midodrine, yohimbine).
Other Name: external abdominal compression (sham)


Outcome Measures
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Primary Outcome Measures :
  1. Increase in seated systolic blood pressure 1-hr post drug compared to baseline. [ Time Frame: 1.5-4 hours ]

Secondary Outcome Measures :
  1. Increase in standing time 1-hr post drug compared to baseline [ Time Frame: 1.5-4 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred for evaluation of their autonomic function
  • Ages 18-85

Exclusion Criteria:

  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223691


Locations
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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Italo Biaggioni, MD Vanderbilt University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Autonomic Dysfunction Center Website  This link exits the ClinicalTrials.gov site

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Italo Biaggioni, Professor of Medicine and Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00223691     History of Changes
Other Study ID Numbers: 000814
HL46681
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by Italo Biaggioni, Vanderbilt University:
orthostatic hypotension
autonomic failure
Additional relevant MeSH terms:
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Hypotension, Orthostatic
Pure Autonomic Failure
Hypotension
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Acarbose
Diphenhydramine
Promethazine
Ibuprofen
Celecoxib
Indomethacin
 Octreotide
Phenylephrine
Acetazolamide
Pseudoephedrine
Oxymetazoline
Ephedrine
Midodrine
Ergotamine
Bromides
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Tranylcypromine
Caffeine
Methylphenidate