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 8, 2021
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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 2025 |
Estimated Study Completion Date : | December 2025 |

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:
|
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:
|
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:
|
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:
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 |
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. |
- Increase in heart rate with standing [ Time Frame: 1-4 hours ]
- Sitting heart rate [ Time Frame: 1-4 hours ]
- Standing heart rate [ Time Frame: 1-4 hours ]
- Blood pressure [ Time Frame: 1-4 hours ]
- Decrease in blood pressure with standing [ Time Frame: 1-4 hours ]
- 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 |
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

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
United States, Tennessee | |
Vanderbilt University Autonomic Dysfunction Center | |
Nashville, Tennessee, United States, 37232-2195 |
Principal Investigator: | Satish R Raj, MD MSCI | Vanderbilt University School of Medicine |
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 |
Other Study ID Numbers: |
008397 UL1TR000445 ( U.S. NIH Grant/Contract ) |
First Posted: | December 6, 2005 Key Record Dates |
Last Update Posted: | September 8, 2021 |
Last Verified: | September 2021 |
tachycardia sinus tachycardia postural tachycardia syndrome (POTS) |
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 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 Protective Agents |