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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02171988

Collaborator

(none)

150

Enrollment

Location

Arms

33.1

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postural Orthostatic Tachycardia Syndrome	Drug: Propranolol Drug: Bisoprolol Drug: Propranolol+pyridostigmine Drug: Bisoprolol+pyridostgmine	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

The change of the subjective symptom survey result after 3-month medical treatment. [3 month after medical treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).