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Treatment of Orthostatic Intolerance

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Vanderbilt University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00262470
First received: December 5, 2005
Last updated: January 7, 2013
Last verified: January 2013

December 5, 2005
January 7, 2013
April 1997
January 2016   (final data collection date for primary outcome measure)
Increase in heart rate with standing [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ]
Increase in heart rate with standing
Complete list of historical versions of study NCT00262470 on ClinicalTrials.gov Archive Site
  • Sitting heart rate [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ]
  • Standing heart rate [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ]
  • Decrease in blood pressure with standing [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ]
  • Orthostatic symptoms score [ Time Frame: Baseline, 2h, 4h ] [ Designated as safety issue: No ]
  • Sitting heart rate
  • Standing heart rate
  • Blood pressure
  • Decrease in blood pressure with standing
  • Orthostatic symptoms score
Not Provided
Not Provided
 
Treatment of Orthostatic Intolerance
Treatment of Orthostatic Intolerance

This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Tachycardia
  • Chronic Orthostatic Intolerance
  • Drug: Acetazolamide
    250 mg PO x 1
    Other Name: Diamox
  • Drug: Atomoxetine
    10-40 mg PO x 1 dose
    Other Name: Strattera
  • Other: NO Drug
    No intervention - just monitoring
  • Drug: Clonidine
    Clonidine 0.05-0.3 mg PO x 1 dose
    Other Name: Catapres
  • Drug: Entacapone
    Entacapone 200-400 mg PO x 1 dose
    Other Name: Comtan
  • Drug: Entacapone & Propranolol
    Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
    Other Names:
    • Comtan
    • Inderal
  • Drug: Atomoxetine & Propranolol
    Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
    Other Names:
    • Strattera
    • Inderal
  • Drug: Indomethacin
    Indomethacin 25-50 mg PO x 1 dose
    Other Name: Indocin
  • Drug: Mecamylamine
    mecamylamine 1.25-5 mg PO x 1 dose
    Other Name: inversine
  • Drug: Isosorbide Dinitrate
    Isosorbide dinitrate 5-20 mg PO x 1 dose
    Other Name: Isordil
  • Dietary Supplement: Melatonin
    melatonin 3 mg PO x 1 dose
  • Drug: Midodrine
    midodrine 2.5-10 mg PO x 1 dose
    Other Name: pro-amatine
  • Drug: Modafinil
    modafinil 100-200 mg PO x 1 dose
    Other Name: provigil
  • Drug: Octreotide
    octreotide 12.5-50 mcg Subcutaneous x 1 dose
    Other Name: sandostatin
  • Radiation: Placebo
    lactose tablet x 1 pill
  • Drug: Propranolol
    Propranolol 10-80 mg PO x 1-2 dose
    Other Name: Inderal
  • Drug: Modafinil & Propranolol
    Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
    Other Names:
    • Provigil
    • Inderal
  • Drug: Sertraline
    sertraline 25-50 mg PO x 1 dose
    Other Name: Zoloft
  • Procedure: IV Saline
    1 liter IV over 2 hours
    Other Name: NaCl solution (0.9%)
  • Other: Drinking Water
    16 fluid ounces
  • Device: Breathing Device
    Breathing through a dead space tube
  • Drug: memantine
    memantine 5-20 mg PO x 1 dose
    Other Name: Namenda
  • Device: Abdominal binder
    Using large blood pressure cuffs linked together, they are wrapped around the subjects abdomen and inflated to generate increased pressure to below tolerably threshold.
  • Experimental: 1
    Acetazolamide
    Intervention: Drug: Acetazolamide
  • Experimental: 2
    Atomoxetine
    Interventions:
    • Drug: Atomoxetine
    • Drug: Atomoxetine & Propranolol
  • Experimental: 3
    NO Drug
    Intervention: Other: NO Drug
  • Experimental: 4
    Clonidine
    Intervention: Drug: Clonidine
  • Experimental: 5
    Entacapone
    Interventions:
    • Drug: Entacapone
    • Drug: Entacapone & Propranolol
  • Experimental: 6
    Indomethacin
    Intervention: Drug: Indomethacin
  • Experimental: 7
    Isosorbide Dinitrate
    Intervention: Drug: Isosorbide Dinitrate
  • Experimental: 8
    Mecamylamine
    Intervention: Drug: Mecamylamine
  • Experimental: 9
    Memantine
    Intervention: Drug: memantine
  • Experimental: 10
    Melatonin
    Intervention: Dietary Supplement: Melatonin
  • Experimental: 11
    Midodrine
    Intervention: Drug: Midodrine
  • Experimental: 12
    Modafinil
    Interventions:
    • Drug: Modafinil
    • Drug: Modafinil & Propranolol
  • Experimental: 13
    Octreotide
    Intervention: Drug: Octreotide
  • Placebo Comparator: 14
    Placebo (lactose tablet)
    Intervention: Radiation: Placebo
  • Experimental: 15
    Propranolol
    Interventions:
    • Drug: Entacapone & Propranolol
    • Drug: Atomoxetine & Propranolol
    • Drug: Propranolol
    • Drug: Modafinil & Propranolol
  • Experimental: 16
    Sertraline
    Intervention: Drug: Sertraline
  • Experimental: 17
    Normal Saline (0.9%) 1 liter
    Intervention: Procedure: IV Saline
  • Experimental: 18
    Drinking Water
    Intervention: Other: Drinking Water
  • Experimental: 19
    Dead Space Breathing Device
    Intervention: Device: Breathing Device
  • Experimental: Abdominal Binder
    Abdominal binder with inflatable pressure over abdomen
    Intervention: Device: Abdominal binder

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic symptoms (> 6 months) with standing upright

Exclusion Criteria:

  • Obvious cause of hypovolemia or drugs that could worsen tachycardia
  • Chronic severe medical conditions such as cancer or ischemic heart disease
Both
18 Years to 70 Years
Yes
Contact: Bonnie K Black, RN NP adcresearch@vanderbilt.edu
United States
 
NCT00262470
008397, GCRC 758, GCRC 1689
No
Satish R. Raj, Vanderbilt University
Satish R. Raj
National Institutes of Health (NIH)
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University School of Medicine
Vanderbilt University
January 2013

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