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| 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 |
| 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:
|
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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
|
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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:
|
|
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
|
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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:
|
|
Experimental: 13
Octreotide
|
Drug: Octreotide
octreotide 12.5-50 mcg Subcutaneous x 1 dose
Other Name: sandostatin
|
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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:
Drug: Atomoxetine & Propranolol
Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Other Names:
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:
|
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bonnie K Black, RN NP | adcresearch@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University Autonomic Dysfunction Center | Recruiting |
| Nashville, Tennessee, United States, 37232-2195 | |
| Principal Investigator: | Satish R Raj, MD MSCI | Vanderbilt University School of Medicine |
More Information
| 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 |
|
tachycardia sinus tachycardia postural tachycardia syndrome (POTS) |
|
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 |