| December 5, 2005 |
| June 23, 2009 |
| April 1997 |
| January 2011 (final data collection date for primary outcome measure) |
| Increase in heart rate with standing [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ] |
| Increase in heart rate with standing |
| Complete list of historical versions of study NCT00262470 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Sitting heart rate
- Standing heart rate
- Blood pressure
- Decrease in blood pressure with standing
- Orthostatic symptoms score
|
| |
| Treatment of Orthostatic Intolerance |
| Treatment of Orthostatic Intolerance |
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. |
| |
| Phase I, Phase II |
| Interventional |
| Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
- Tachycardia
- Chronic Orthostatic Intolerance
|
- 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
|
- Experimental: Acetazolamide
- Experimental: Atomoxetine
- No Intervention: NO Drug to look at natural history over 4 hour duration of follow-up
- Experimental: Clonidine
- Experimental: Entacapone
- Experimental: Indomethacin
- Experimental: Isosorbide Dinitrate
- Experimental: Mecamylamine
- Experimental: Memantine
- Experimental: Melatonin
- Experimental: Midodrine
- Experimental: Modafinil
- Experimental: Octreotide
- Placebo Comparator: Placebo (lactose tablet)
- Experimental: Propranolol
- Experimental: Sertraline
- Experimental: Normal Saline (0.9%) 1 liter
- Experimental: Drinking Water
- Experimental: Dead Space Breathing Device
|
| 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. |
| |
| Recruiting |
| 150 |
|
| January 2011 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 70 Years |
| Yes |
|
|
| United States |
| |
| NCT00262470 |
| Satish Raj MD MSCI, Vanderbilt University |
| 008397, GCRC 758, GCRC 1689 |
| Vanderbilt University |
| National Heart, Lung, and Blood Institute (NHLBI) |
| Principal Investigator: |
Satish R Raj, MD MSCI |
Vanderbilt University School of Medicine |
|
|
| Vanderbilt University |
| June 2009 |
