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Treatment of Orthostatic Intolerance

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ClinicalTrials.gov Identifier: NCT00262470
Recruitment Status : Active, not recruiting
First Posted : December 6, 2005
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University

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 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 2021
Estimated Study Completion Date : December 2021

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.




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 ]


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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

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
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
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University School of Medicine

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00262470     History of Changes
Other Study ID Numbers: 008397
UL1TR000445 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Satish R. Raj, Vanderbilt University:
tachycardia
sinus tachycardia
postural tachycardia syndrome (POTS)

Additional relevant MeSH terms:
Tachycardia
Orthostatic Intolerance
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Melatonin
Propranolol
Clonidine
Mecamylamine
Isosorbide-5-mononitrate
Isosorbide Dinitrate
Atomoxetine Hydrochloride
Midodrine
Sertraline
Memantine
Entacapone
Indomethacin
Octreotide
Modafinil
Armodafinil
Acetazolamide
Isosorbide
Antioxidants
Molecular Mechanisms of Pharmacological Action