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...
Date First Received: December 5, 2005
Last Updated: June 2, 2008
Verified by: Vanderbilt University, June 2008
Clinical Trial Phase: Phase 1/Phase 2 | Start Date: April 1997
Overall Status: Recruiting
Estimated Enrollment: 150
Brief Summary
Official Title: “Treatment of Orthostatic Intolerance”
Condition Keyword(s):
Intervention(s):
- 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
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- Increase in heart rate with standing 1-4 hours No
Secondary:
- Sitting heart rate 1-4 hours No
- Standing heart rate 1-4 hours No
- Blood pressure 1-4 hours No
- Decrease in blood pressure with standing 1-4 hours No
- Orthostatic symptoms score Baseline, 2h, 4h No
Criteria for Participation in this Clinical Trial
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
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Vanderbilt University
Vanderbilt University Autonomic Dysfunction Center
Nashville Tennessee 37232-2195 United States
Overall Clinical Trial Officials and Contacts
Satish R Raj, MD MSCI Principal Investigator Vanderbilt University School of Medicine
Overall Contact: Bonnie K Black, RN NP adcresearch@vanderbilt.edu
Related Publications
Citations Reporting Results
Raj SR, Black BK, Biaggioni I, Harris PA, Robertson D. Acetylcholinesterase inhibition improves tachycardia in postural tachycardia syndrome. Circulation. 2005 May 31;111(21):2734-40. Epub 2005 May 23.
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00262470
Study ID Number: 008397
ClinicalTrials.gov Identifier: NCT00262470
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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