Autonomic Failure | Treatment of Orthostatic Hypotension in Autonomic Failure
Autonomic Failure research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Patients referred for evaluation of their autonomic function - Ages 18-85 Exclusion Criteria: - Pregnancy
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Atomoxetine10-50 mg, PO. Single dose. Alone or in combination with Yohimbine or Mestinon.
Drug:Acarbose25-100 mg, PO. Single dose.
Drug:Pyridostigmine Bromide30 mg-180 mg PO. Single dose. Alone or in combination with Yohimbine or atomoxetine.
Drug:Yohimbine2.7, 5.4 or 10.8 mg PO. Single dose. Alone or in combination with Atomoxetine or Pyridostigmine.
Drug:Midodrine HCl2.5, 5.0, 7.5, 10 mg PO. Single dose
Drug:Modafinil50-400 mg PO. Single dose
Drug:Octreotide5-50 µg, S.C. Single dose.
Other:water intakeTap water 2 onz., 8 oz., 16 oz. PO, alone or in combination with any of the above medications. Single dose.
Drug:Diphenhydramine Hydrochloride12.5 mg-100 mg PO. Single dose. Alone or in combination with Ranitidine
Drug:Ranitidine HCL150-300 mg PO. Single dose. Alone or in combination with Diphenhydramine.
Drug:Tranylcypromine5 - 40 mg PO. Single dose
Drug:Ergotamine/ CaffeineErgotamine: 1.0 mg PO. Single dose. Caffeine 100 mg PO.Single dose
Drug:Celecoxib50-200 mg PO. Single dose
Drug:Pseudoephedrine15, 30 or 60 mg, PO. Single dose.
Drug:Methylphenidate5 or 10 mg PO. Single dose.
Drug:Indomethacin25, 50 or 75 mg, PO. Singe dose.
Drug:Ibuprofen300, 600 or 900 mg, PO. Single dose.
Drug:Oxymetazoline 0.05% nasal solution1-2 sprays/ nostril. Single dose.
Dietary Supplement:Bovril6-10 g, PO. Single dose.
Drug:Acetazolamide125-1000 mg PO. Single dose. Alone or in combination with yohimbine or midodrine
Drug:Rivastigmine tartrate1.5-6 mg PO. Single dose.
Drug:Carbidopa/levodopa10mg/100mg or 25mg/100mg. 1-2 tab PO. Single dose. Alone or in combination with carbidopa (Lodosyn) 25-175 mg
Device:Inflatable abdominal binderExternal abdominal compression (20-40 mm Hg) with an inflatable abdominal binder applied after a pressor agent (e.g. midodrine, yohimbine).
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).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1: active interventionatomoxetine, 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
2: Placebo or sham deviceplacebo pill or inflatable abdominal binder (sham)
Start Date: March 2002
Completed Date: January 2017
Phase: Phase 1
Primary Outcome: Increase in seated systolic blood pressure 1-hr post drug compared to baseline.
Secondary Outcome: Increase in standing time 1-hr post drug compared to baseline
Study sponsors, principal investigator, and references
Principal Investigator: Italo Biaggioni, MD
Lead Sponsor: Vanderbilt University
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