Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
150 participants
INTERVENTIONAL
1997-04-30
2029-12-31
Brief Summary
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Detailed Description
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Pilot drug trials are 4h in duration from \~9am -1pm. Different short-acting medications will be used to determine their acute hemodynamic effects in patients with orthostatic intolerance.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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1
Acetazolamide
Acetazolamide
250 mg PO x 1
2
Atomoxetine
Atomoxetine
10-40 mg PO x 1 dose
Atomoxetine & Propranolol
Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
3
NO Drug
NO Drug
No intervention - just monitoring
4
Clonidine
Clonidine
Clonidine 0.05-0.3 mg PO x 1 dose
5
Entacapone
Entacapone
Entacapone 200-400 mg PO x 1 dose
Entacapone & Propranolol
Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
6
Indomethacin
Indomethacin
Indomethacin 25-50 mg PO x 1 dose
7
Isosorbide Dinitrate
Isosorbide Dinitrate
Isosorbide dinitrate 5-20 mg PO x 1 dose
8
Mecamylamine
Mecamylamine
mecamylamine 1.25-5 mg PO x 1 dose
9
Memantine
memantine
memantine 5-20 mg PO x 1 dose
10
Melatonin
Melatonin
melatonin 3 mg PO x 1 dose
11
Midodrine
Midodrine
midodrine 2.5-10 mg PO x 1 dose
12
Modafinil
Modafinil
modafinil 100-200 mg PO x 1 dose
Modafinil & Propranolol
Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
13
Octreotide
Octreotide
octreotide 12.5-50 mcg Subcutaneous x 1 dose
14
Placebo (lactose tablet)
Placebo
lactose tablet x 1 pill
15
Propranolol
Entacapone & Propranolol
Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Atomoxetine & Propranolol
Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Propranolol
Propranolol 10-80 mg PO x 1-2 dose
Modafinil & Propranolol
Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
16
Sertraline
Sertraline
sertraline 25-50 mg PO x 1 dose
17
Normal Saline (0.9%) 1 liter
IV Saline
1 liter IV over 2 hours
18
Drinking Water
Drinking Water
16 fluid ounces
19
Dead Space Breathing Device
Breathing Device
Breathing through a dead space tube
Abdominal Binder
Abdominal binder with inflatable pressure over abdomen
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.
Interventions
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Acetazolamide
250 mg PO x 1
Atomoxetine
10-40 mg PO x 1 dose
NO Drug
No intervention - just monitoring
Clonidine
Clonidine 0.05-0.3 mg PO x 1 dose
Entacapone
Entacapone 200-400 mg PO x 1 dose
Entacapone & Propranolol
Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Atomoxetine & Propranolol
Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Indomethacin
Indomethacin 25-50 mg PO x 1 dose
Mecamylamine
mecamylamine 1.25-5 mg PO x 1 dose
Isosorbide Dinitrate
Isosorbide dinitrate 5-20 mg PO x 1 dose
Melatonin
melatonin 3 mg PO x 1 dose
Midodrine
midodrine 2.5-10 mg PO x 1 dose
Modafinil
modafinil 100-200 mg PO x 1 dose
Octreotide
octreotide 12.5-50 mcg Subcutaneous x 1 dose
Placebo
lactose tablet x 1 pill
Propranolol
Propranolol 10-80 mg PO x 1-2 dose
Modafinil & Propranolol
Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
Sertraline
sertraline 25-50 mg PO x 1 dose
IV Saline
1 liter IV over 2 hours
Drinking Water
16 fluid ounces
Breathing Device
Breathing through a dead space tube
memantine
memantine 5-20 mg PO x 1 dose
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Chronic severe medical conditions such as cancer or ischemic heart disease
18 Years
70 Years
ALL
Yes
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
Satish R. Raj
OTHER
Responsible Party
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Satish R. Raj
Assistant Professor of Medicine & Pharmacology
Principal Investigators
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Satish R Raj, MD MSCI
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University School of Medicine
Locations
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Vanderbilt University Autonomic Dysfunction Center
Nashville, Tennessee, United States
Countries
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References
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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. doi: 10.1161/CIRCULATIONAHA.104.497594. Epub 2005 May 23.
Raj SR, Black BK, Biaggioni I, Paranjape SY, Ramirez M, Dupont WD, Robertson D. Propranolol decreases tachycardia and improves symptoms in the postural tachycardia syndrome: less is more. Circulation. 2009 Sep 1;120(9):725-34. doi: 10.1161/CIRCULATIONAHA.108.846501. Epub 2009 Aug 17.
Smith EC, Diedrich A, Raj SR, Gamboa A, Shibao CA, Black BK, Peltier A, Paranjape SY, Biaggioni I, Okamoto LE. Splanchnic Venous Compression Enhances the Effects of ss-Blockade in the Treatment of Postural Tachycardia Syndrome. J Am Heart Assoc. 2020 Jul 21;9(14):e016196. doi: 10.1161/JAHA.120.016196. Epub 2020 Jul 16.
Nwazue VC, Paranjape SY, Black BK, Biaggioni I, Diedrich A, Dupont WD, Robertson D, Raj SR. Postural tachycardia syndrome and inappropriate sinus tachycardia: role of autonomic modulation and sinus node automaticity. J Am Heart Assoc. 2014 Apr 10;3(2):e000700. doi: 10.1161/JAHA.113.000700.
Nwazue VC, Arnold AC, Raj V, Black BK, Biaggioni I, Paranjape SY, Orozco C, Dupont WD, Robertson D, Raj SR. Understanding the placebo effect in clinical trials for postural tachycardia syndrome. Clin Exp Pharmacol Physiol. 2014 May;41(5):325-30. doi: 10.1111/1440-1681.12221.
Green EA, Black BK, Biaggioni I, Paranjape SY, Bagai K, Shibao C, Okoye MC, Dupont WD, Robertson D, Raj SR. Melatonin reduces tachycardia in postural tachycardia syndrome: a randomized, crossover trial. Cardiovasc Ther. 2014 Jun;32(3):105-12. doi: 10.1111/1755-5922.12067.
Mar PL, Raj V, Black BK, Biaggioni I, Shibao CA, Paranjape SY, Dupont WD, Robertson D, Raj SR. Acute hemodynamic effects of a selective serotonin reuptake inhibitor in postural tachycardia syndrome: a randomized, crossover trial. J Psychopharmacol. 2014 Feb;28(2):155-61. doi: 10.1177/0269881113512911. Epub 2013 Nov 13.
Green EA, Raj V, Shibao CA, Biaggioni I, Black BK, Dupont WD, Robertson D, Raj SR. Effects of norepinephrine reuptake inhibition on postural tachycardia syndrome. J Am Heart Assoc. 2013 Sep 3;2(5):e000395. doi: 10.1161/JAHA.113.000395.
Related Links
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Vanderbilt University Autonomic Dysfunction Center website
Other Identifiers
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008397
Identifier Type: -
Identifier Source: org_study_id
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