Trial record 1 of 48 for:
Open Studies | "Orthostatic Intolerance"
Treatment of Orthostatic Intolerance
This study is currently recruiting participants.
Verified January 2013 by Vanderbilt University
Sponsor:
Satish R. Raj
Collaborator:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00262470
First received: December 5, 2005
Last updated: January 7, 2013
Last verified: January 2013
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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: 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 |
| 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:
Drug Information available for:
Indomethacin
Acetazolamide
Mecamylamine
Melatonin
Isosorbide dinitrate
Propranolol hydrochloride
Propranolol
Isosorbide
Mecamylamine hydrochloride
Acetazolamide sodium
Clonidine
Clonidine hydrochloride
Isosorbide mononitrate
Memantine
Memantine hydrochloride
Midodrine hydrochloride
Modafinil
Octreotide acetate
Sertraline hydrochloride
Sertraline
Atomoxetine hydrochloride
Atomoxetine
Octreotide
Armodafinil
Entacapone
U.S. FDA Resources
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 2016 (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:
|
|
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.
|
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
Satish R. Raj
Investigators
| Principal Investigator: | Satish R Raj, MD MSCI | Vanderbilt University School of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Satish R. Raj, Assistant Professor of Medicine & Pharmacology, 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: | January 7, 2013 |
| 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 May 21, 2013