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Treatment of Orthostatic Hypotension in Autonomic Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00223691
First received: September 14, 2005
Last updated: November 20, 2014
Last verified: November 2014
  Purpose

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 Intervention 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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation and Treatment of Autonomic Failure.

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Increase in seated systolic blood pressure 1-hr post drug compared to baseline. [ Time Frame: 1.5-4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase in standing time 1-hr post drug compared to baseline [ Time Frame: 1.5-4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2002
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223691

Contacts
Contact: Bonnie Black, RN adcresearch@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Bonnie Black, RN       adcresearch@vanderbilt.edu   
Principal Investigator: Biaggioni Italo, MD         
Sub-Investigator: Cyndya Shibao, MD         
Sub-Investigator: David Robertson, MD         
Sub-Investigator: Andre Diedrich, MD         
Sub-Investigator: Alfredo Gamboa, MD         
Sub-Investigator: Satish Raj, MD         
Sub-Investigator: Luis E Okamoto, MD         
Sub-Investigator: Amy C Arnold, PhD         
Sub-Investigator: Cindy A Dorminy, MEd, LPN         
Sub-Investigator: Emily M Garland, PhD         
Sub-Investigator: Melissa R Kaufman, MD, PhD         
Sub-Investigator: Claudia Ramirez, MD         
Sub-Investigator: Jorge Celedonio, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Italo Biaggioni, MD Vanderbilt University
  More Information

Additional Information:
Publications:

Responsible Party: Italo Biaggioni, Professor of Medicine and Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00223691     History of Changes
Other Study ID Numbers: 000814, HL46681
Study First Received: September 14, 2005
Last Updated: November 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
orthostatic hypotension
autonomic failure

Additional relevant MeSH terms:
Hypotension, Orthostatic
Hypotension
Pure Autonomic Failure
Autonomic Nervous System Diseases
Cardiovascular Diseases
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Vascular Diseases
Acetazolamide
Atomoxetine
Caffeine
Carbidopa
Carbidopa, levodopa drug combination
Celecoxib
Diphenhydramine
Ephedrine
Ergotamine
Ibuprofen
Indomethacin
Levodopa
Methylphenidate
Midodrine
Modafinil
Octreotide
Oxymetazoline
Phenylephrine
Promethazine
Pseudoephedrine
Pyridostigmine Bromide

ClinicalTrials.gov processed this record on November 27, 2014