Effect of Medical Treatment and Prognosis of Postural Orthostatic Tachycardia Syndrome (POTS)

Study Overview
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Brief Summary
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The purpose of the study is to investigate effect of medical treatment and prognosis of Postural Orthostatic Tachycardia Syndrome (POTS)

Detailed Description
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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.

Official Title
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Comparison of Effect of Propranolol, Bisoprolol, Pyridosgitmine in Postural Orthostatic Tachycardia Syndrome (POTS) and Prognosis After Medical Treatment

Conditions
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Postural Orthostatic Tachycardia Syndrome

Intervention / Treatment
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* Drug: Propranolol
* Drug: Bisoprolol
* Drug: Propranolol+pyridostigmine
* Drug: Bisoprolol+pyridostgmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 15<= developed symptoms of orthostatic intolerance accompanied by a HR rise ≥30 min-1 within the first 10 minutes of standing, HR rise ≥ 120 in the absence of orthostatic hypotension (a fall in blood pressure [BP] >20/10 mm Hg). Exclusion Criteria: poor drug compliance patients who cannot or do not want to write questionaires. patients who do not want draw blood

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propranolol<br>Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable | Drug: Propranolol<br>* Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable<br>|
| Active Comparator: Bisoprolol<br>Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable | Drug: Bisoprolol<br>* Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable<br>|
| Active Comparator: Propranolol+pyridostigmine<br>Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable. | Drug: Propranolol+pyridostigmine<br>* Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.<br>|
| Active Comparator: Bisoprolol+pyridostgmine<br>start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable | Drug: Bisoprolol+pyridostgmine<br>* Start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the subjective symptom survey result after 3-month medical treatment. |  | 3 month after medical treatment | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Change of quality of life score after treatment |  | 6 month | 
| Change of depression score after treatment |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postural Orthostatic Tachycardia Syndrome, propranolol, bisoprolol, pyridostigmine