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The purpose of the study is to investigate effect of medical treatment and prognosis of Postural Orthostatic Tachycardia Syndrome (POTS)
Many patients who complained of dizziness are eventually diagnosed as POTS. However, the investigation of an appropriate medical treatment of POTS has not been enough yet. Also, the prognosis of the disease after treatment is not well known. It is known that propranolol attenuate the tachycardia and improve symptom burden in patients with POTS. However, the effect of other β-Blocker, bisoprolol compared with propranolol is not known well. In addition, acetylcholinesterase inhibition with pyridostigmine was a effective method of acutely decreasing the tachycardia in patients with POTS. However, difference among three medical treatments effect is not known and long-term studies are not done yet. Therefore, in this study investigator investigate effect of medical treatment (propranolol only, bisoprolol only, propranolol+pyridostigmine, bisoprolol+pyridostigmine) and prognosis of Postural Orthostatic Tachycardia Syndrome.
Longer-term studies are needed to assess this promising therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol | Active Comparator | Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable |
|
| Bisoprolol | Active Comparator | Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable |
|
| Propranolol+pyridostigmine | Active Comparator | Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable. |
|
| Bisoprolol+pyridostgmine | Active Comparator | start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol | Drug | Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of the subjective symptom survey result after 3-month medical treatment. | 3 month after medical treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Normalization of orthostatic BP-HR test after 6-month medical treatment. | 6 month | |
| The change of the subjective symptom after 6-month medical treatment. | 6 month | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kon Chu, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15911704 | Background | 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 | Background | 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. |
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| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| D017298 | Bisoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Bisoprolol | Drug | Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable |
|
| Propranolol+pyridostigmine | Drug | Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable. |
|
| Bisoprolol+pyridostgmine | Drug | Start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable |
|
| Change of quality of life score after treatment |
| 6 month |
| Change of depression score after treatment | 6 month |
| 21690484 | Background | Fu Q, Vangundy TB, Shibata S, Auchus RJ, Williams GH, Levine BD. Exercise training versus propranolol in the treatment of the postural orthostatic tachycardia syndrome. Hypertension. 2011 Aug;58(2):167-75. doi: 10.1161/HYPERTENSIONAHA.111.172262. Epub 2011 Jun 20. |
| 22795533 | Background | Kimpinski K, Figueroa JJ, Singer W, Sletten DM, Iodice V, Sandroni P, Fischer PR, Opfer-Gehrking TL, Gehrking JA, Low PA. A prospective, 1-year follow-up study of postural tachycardia syndrome. Mayo Clin Proc. 2012 Aug;87(8):746-52. doi: 10.1016/j.mayocp.2012.02.020. Epub 2012 Jul 15. |
| 22190289 | Background | Sousa A, Lebreiro A, Freitas J, Maciel MJ. Long-term follow-up of patients with postural tachycardia syndrome. Clin Auton Res. 2012 Jun;22(3):151-3. doi: 10.1007/s10286-011-0155-1. Epub 2011 Dec 22. |
| 15699447 | Background | Winker R, Barth A, Bidmon D, Ponocny I, Weber M, Mayr O, Robertson D, Diedrich A, Maier R, Pilger A, Haber P, Rudiger HW. Endurance exercise training in orthostatic intolerance: a randomized, controlled trial. Hypertension. 2005 Mar;45(3):391-8. doi: 10.1161/01.HYP.0000156540.25707.af. Epub 2005 Feb 7. |
| 23616163 | Background | Arnold AC, Okamoto LE, Diedrich A, Paranjape SY, Raj SR, Biaggioni I, Gamboa A. Low-dose propranolol and exercise capacity in postural tachycardia syndrome: a randomized study. Neurology. 2013 May 21;80(21):1927-33. doi: 10.1212/WNL.0b013e318293e310. Epub 2013 Apr 24. |
| 23122672 | Background | Benarroch EE. Postural tachycardia syndrome: a heterogeneous and multifactorial disorder. Mayo Clin Proc. 2012 Dec;87(12):1214-25. doi: 10.1016/j.mayocp.2012.08.013. Epub 2012 Nov 1. |
| 22143364 | Background | Mathias CJ, Low DA, Iodice V, Owens AP, Kirbis M, Grahame R. Postural tachycardia syndrome--current experience and concepts. Nat Rev Neurol. 2011 Dec 6;8(1):22-34. doi: 10.1038/nrneurol.2011.187. |
| 29500811 | Derived | Moon J, Kim DY, Lee WJ, Lee HS, Lim JA, Kim TJ, Jun JS, Park B, Byun JI, Sunwoo JS, Lee ST, Jung KH, Park KI, Jung KY, Kim M, Lee SK, Chu K. Efficacy of Propranolol, Bisoprolol, and Pyridostigmine for Postural Tachycardia Syndrome: a Randomized Clinical Trial. Neurotherapeutics. 2018 Jul;15(3):785-795. doi: 10.1007/s13311-018-0612-9. |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |