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Treatment of Orthostatic Intolerance
This study is currently recruiting participants.
Verified June 2011 by Vanderbilt University

First Received on December 5, 2005.   Last Updated on June 24, 2011   History of Changes
Sponsor: Vanderbilt University
Collaborator: National Institutes of Health (NIH)
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00262470
  Purpose

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.


Condition Intervention Phase
Tachycardia
Chronic Orthostatic Intolerance
Drug: Acetazolamide
Drug: Atomoxetine
Other: Baseline (No Drug)
Drug: Clonidine
Drug: Entacapone
Drug: Entacapone & Propranolol
Drug: Atomoxetine & Propranolol
Drug: Indomethacin
Drug: Mecamylamine
Drug: Isosorbide Dinitrate
Dietary Supplement: Melatonin
Drug: Midodrine
Drug: Modafinil
Drug: Octreotide
Radiation: Placebo
Drug: Propranolol
Drug: Modafinil & Propranolol
Drug: Sertraline
Procedure: IV Saline
Other: Drinking Water
Device: Breathing Device
Drug: memantine
Phase I
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment of Orthostatic Intolerance

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Increase in heart rate with standing [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: April 1997
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Acetazolamide
Drug: Acetazolamide
250 mg PO x 1
Other Name: Diamox
Experimental: 2
Atomoxetine
Drug: Atomoxetine
10-40 mg PO x 1 dose
Other Name: Strattera
Drug: Atomoxetine & Propranolol
Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Other Names:
  • Strattera
  • Inderal
No Intervention: 3
NO Drug to look at natural history over 4 hour duration of follow-up
Other: Baseline (No Drug)
No intervention - just monitoring
Experimental: 4
Clonidine
Drug: Clonidine
Clonidine 0.05-0.3 mg PO x 1 dose
Other Name: Catapres
Experimental: 5
Entacapone
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
Experimental: 6
Indomethacin
Drug: Indomethacin
Indomethacin 25-50 mg PO x 1 dose
Other Name: Indocin
Experimental: 7
Isosorbide Dinitrate
Drug: Isosorbide Dinitrate
Isosorbide dinitrate 5-20 mg PO x 1 dose
Other Name: Isordil
Experimental: 8
Mecamylamine
Drug: Mecamylamine
mecamylamine 1.25-5 mg PO x 1 dose
Other Name: inversine
Experimental: 9
Memantine
Drug: memantine
memantine 5-20 mg PO x 1 dose
Other Name: Namenda
Experimental: 10
Melatonin
Dietary Supplement: Melatonin
melatonin 3 mg PO x 1 dose
Experimental: 11
Midodrine
Drug: Midodrine
midodrine 2.5-10 mg PO x 1 dose
Other Name: pro-amatine
Experimental: 12
Modafinil
Drug: Modafinil
modafinil 100-200 mg PO x 1 dose
Other Name: provigil
Drug: Modafinil & Propranolol
Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
Other Names:
  • Provigil
  • Inderal
Experimental: 13
Octreotide
Drug: Octreotide
octreotide 12.5-50 mcg Subcutaneous x 1 dose
Other Name: sandostatin
Placebo Comparator: 14
Placebo (lactose tablet)
Radiation: Placebo
lactose tablet x 1 pill
Experimental: 15
Propranolol
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: 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
Experimental: 16
Sertraline
Drug: Sertraline
sertraline 25-50 mg PO x 1 dose
Other Name: Zoloft
Experimental: 17
Normal Saline (0.9%) 1 liter
Procedure: IV Saline
1 liter IV over 2 hours
Other Name: NaCl solution (0.9%)
Experimental: 18
Drinking Water
Other: Drinking Water
16 fluid ounces
Experimental: 19
Dead Space Breathing Device
Device: Breathing Device
Breathing through a dead space tube

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262470

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

Locations
United States, Tennessee
Vanderbilt University Autonomic Dysfunction Center Recruiting
Nashville, Tennessee, United States, 37232-2195
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Satish Raj MD MSCI, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00262470     History of Changes
Other Study ID Numbers: 008397, GCRC 758, GCRC 1689
Study First Received: December 5, 2005
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
tachycardia
sinus tachycardia
postural tachycardia syndrome (POTS)

Additional relevant MeSH terms:
Orthostatic Intolerance
Mitral Valve Prolapse
Neurocirculatory Asthenia
Tachycardia
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Heart Valve Prolapse
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Anxiety Disorders
Mental Disorders
Arrhythmias, Cardiac
Pathologic Processes
Acetazolamide
Isosorbide
Clonidine
Melatonin
Memantine
Modafinil
Sertraline
Entacapone
Indomethacin
Propranolol
Mecamylamine
Midodrine
Atomoxetine

ClinicalTrials.gov processed this record on February 12, 2012