Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000445 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Acetazolamide |
|
| 2 | Experimental | Atomoxetine |
|
| 3 | Experimental | NO Drug |
|
| 4 | Experimental | Clonidine |
|
| 5 | Experimental | Entacapone |
|
| 6 | Experimental | Indomethacin |
|
| 7 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | 250 mg PO x 1 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in heart rate with standing | 1-4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sitting heart rate | 1-4 hours | |
| Standing heart rate | 1-4 hours | |
| Blood pressure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Satish R Raj, MD MSCI | Vanderbilt University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Autonomic Dysfunction Center | Nashville | Tennessee | 37232-2195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15911704 | Result | 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. | |
| 19687359 | Result | 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. |
| Label | URL |
|---|---|
| Vanderbilt University Autonomic Dysfunction Center website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Isosorbide Dinitrate |
|
| 8 | Experimental | Mecamylamine |
|
| 9 | Experimental | Memantine |
|
| 10 | Experimental | Melatonin |
|
| 11 | Experimental | Midodrine |
|
| 12 | Experimental | Modafinil |
|
| 13 | Experimental | Octreotide |
|
| 14 | Placebo Comparator | Placebo (lactose tablet) |
|
| 15 | Experimental | Propranolol |
|
| 16 | Experimental | Sertraline |
|
| 17 | Experimental | Normal Saline (0.9%) 1 liter |
|
| 18 | Experimental | Drinking Water |
|
| 19 | Experimental | Dead Space Breathing Device |
|
| Abdominal Binder | Experimental | Abdominal binder with inflatable pressure over abdomen |
|
| Atomoxetine |
| Drug |
10-40 mg PO x 1 dose |
|
|
| NO Drug | Other | No intervention - just monitoring |
|
| Clonidine | Drug | Clonidine 0.05-0.3 mg PO x 1 dose |
|
|
| Entacapone | Drug | Entacapone 200-400 mg PO x 1 dose |
|
|
| Entacapone & Propranolol | Drug | Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose |
|
|
| Atomoxetine & Propranolol | Drug | Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose |
|
|
| Indomethacin | Drug | Indomethacin 25-50 mg PO x 1 dose |
|
|
| Mecamylamine | Drug | mecamylamine 1.25-5 mg PO x 1 dose |
|
|
| Isosorbide Dinitrate | Drug | Isosorbide dinitrate 5-20 mg PO x 1 dose |
|
|
| Melatonin | Dietary Supplement | melatonin 3 mg PO x 1 dose |
|
| Midodrine | Drug | midodrine 2.5-10 mg PO x 1 dose |
|
|
| Modafinil | Drug | modafinil 100-200 mg PO x 1 dose |
|
|
| Octreotide | Drug | octreotide 12.5-50 mcg Subcutaneous x 1 dose |
|
|
| Placebo | Radiation | lactose tablet x 1 pill |
|
| Propranolol | Drug | Propranolol 10-80 mg PO x 1-2 dose |
|
|
| Modafinil & Propranolol | Drug | Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose |
|
|
| Sertraline | Drug | sertraline 25-50 mg PO x 1 dose |
|
|
| IV Saline | Procedure | 1 liter IV over 2 hours |
|
|
| Drinking Water | Other | 16 fluid ounces |
|
| Breathing Device | Device | Breathing through a dead space tube |
|
| memantine | Drug | memantine 5-20 mg PO x 1 dose |
|
|
| Abdominal binder | Device | Using large blood pressure cuffs linked together, they are wrapped around the subjects abdomen and inflated to generate increased pressure to below tolerably threshold. |
|
| 1-4 hours |
| Decrease in blood pressure with standing | 1-4 hours |
| Orthostatic symptoms score | Baseline, 2h, 4h |
| 32673517 | Derived | 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. |
| 24721800 | Derived | 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. |
| 24606242 | Derived | 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. |
| 24495468 | Derived | 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. |
| 24227635 | Derived | 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. |
| 24002370 | Derived | 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. |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D013616 | Tachycardia, Sinus |
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013617 | Tachycardia, Supraventricular |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| D000069445 | Atomoxetine Hydrochloride |
| D003000 | Clonidine |
| C071192 | entacapone |
| D011433 | Propranolol |
| D007213 | Indomethacin |
| D008464 | Mecamylamine |
| D007548 | Isosorbide Dinitrate |
| D008550 | Melatonin |
| D008879 | Midodrine |
| D000077408 | Modafinil |
| D015282 | Octreotide |
| D020280 | Sertraline |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| D060766 | Drinking Water |
| D008559 | Memantine |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009636 | Norbornanes |
| D001643 | Bridged Bicyclo Compounds |
| D001952 | Bridged-Ring Compounds |
| D007547 | Isosorbide |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D002241 | Carbohydrates |
| D014363 | Tryptamines |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004983 | Ethanolamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015057 | 1-Naphthylamine |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D000547 | Amantadine |
| D000218 | Adamantane |
Not provided
Not provided