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Treatment of Orthostatic Intolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00262470
Recruitment Status : Active, not recruiting
First Posted : December 6, 2005
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Tachycardia Chronic Orthostatic Intolerance Drug: Acetazolamide Drug: Atomoxetine Other: 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 Device: Abdominal binder Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Orthostatic Intolerance
Actual Study Start Date : April 1997
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
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Arm Intervention/treatment
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
Experimental: 3
NO Drug
 Other: 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
Experimental: Abdominal Binder
Abdominal binder with inflatable pressure over abdomen
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Increase in heart rate with standing [ Time Frame: 1-4 hours ]

Secondary Outcome Measures :
  1. Sitting heart rate [ Time Frame: 1-4 hours ]
  2. Standing heart rate [ Time Frame: 1-4 hours ]
  3. Blood pressure [ Time Frame: 1-4 hours ]
  4. Decrease in blood pressure with standing [ Time Frame: 1-4 hours ]
  5. Orthostatic symptoms score [ Time Frame: Baseline, 2h, 4h ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00262470


Locations
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United States, Tennessee
Vanderbilt University Autonomic Dysfunction Center
Nashville, Tennessee, United States, 37232-2195
Sponsors and Collaborators
Satish R. Raj
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University School of Medicine
More Information
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Additional Information:
Vanderbilt University Autonomic Dysfunction Center website  This link exits the ClinicalTrials.gov site

Publications of Results:

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

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Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00262470    
Other Study ID Numbers: 008397
UL1TR000445 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Keywords provided by Satish R. Raj, Vanderbilt University:
tachycardia
sinus tachycardia
postural tachycardia syndrome (POTS)
Additional relevant MeSH terms:
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Orthostatic Intolerance
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Indomethacin
Octreotide
Propranolol
 Clonidine
Mecamylamine
Acetazolamide
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Midodrine
Memantine
Entacapone
Melatonin
Modafinil
Sertraline
Atomoxetine Hydrochloride
Antioxidants
Molecular Mechanisms of Pharmacological Action