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

Phase 4

Completed

• Conditions: Postural Orthostatic Tachycardia Syndrome
• Interventions: Drug: Propranolol+pyridostigmine; Drug: Propranolol; Drug: Bisoprolol+pyridostgmine; Drug: Bisoprolol

• Registration Number: NCT02171988
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-22
• Study First Posted: 2014-06-24
• Primary Completion: 2016-02
• Study Completion: 2016-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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).

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Exclusion Criteria

• poor drug compliance
• patients who cannot or do not want to write questionaires.
• patients who do not want draw blood

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propranolol+pyridostigmine	Propranolol+pyridostigmine	Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.
Propranolol	Propranolol	Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable
Bisoprolol+pyridostgmine	Bisoprolol+pyridostgmine	start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable
Bisoprolol	Bisoprolol	Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable

Primary Outcome Measures

Name	Time	Method
The change of the subjective symptom survey result after 3-month medical treatment.	3 month after medical treatment

Secondary Outcome Measures

Name	Time	Method
The change of the subjective symptom after 6-month medical treatment.	6 month
Change of quality of life score after treatment	6 month
Normalization of orthostatic BP-HR test after 6-month medical treatment.	6 month
Change of depression score after treatment	6 month

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of