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Treatment of Orthostatic Intolerance

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00262470
First received: December 5, 2005
Last updated: August 15, 2016
Last verified: August 2016
  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
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Orthostatic Intolerance

Further study details as provided by Satish R. Raj, Vanderbilt University:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: April 1997
Estimated Primary Completion Date: January 2018 (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:
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
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 )
Study First Received: December 5, 2005
Last Updated: August 15, 2016

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

ClinicalTrials.gov processed this record on July 27, 2017