Trial record 17 of 65 for:    arrhythmia OR atrial fibrillation OR ventricular fibrillation OR tachycardia OR bradycardia | Open Studies | NIH, U.S. Fed

Treatment of Orthostatic Intolerance

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Vanderbilt University
Sponsor:
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
  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:


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:
  • 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
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
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

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:
Additional 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, 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:
Tachycardia
Arrhythmias, Cardiac
Anti-Arrhythmia Agents
Orthostatic Intolerance
Mitral Valve Prolapse
Neurocirculatory Asthenia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Heart Valve Prolapse
Heart Valve Diseases
Anxiety Disorders
Mental Disorders
Melatonin
Sertraline
Memantine
Clonidine
Modafinil
Armodafinil
Acetazolamide
Entacapone
Propranolol
Atomoxetine
Midodrine
Mecamylamine

ClinicalTrials.gov processed this record on September 16, 2014