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

Phase 4CompletedNCT02171988

Seoul National University Hospital150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

PropranololDRUG

Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable

BisoprololDRUG

Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable

Propranolol+pyridostigmineDRUG

Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 3 month after medical treatment

Secondary Outcomes

Normalization of orthostatic BP-HR test after 6-month medical treatment.

Time frame: 6 month

The change of the subjective symptom after 6-month medical treatment.

Time frame: 6 month

Change of quality of life score after treatment

Time frame: 6 month

Change of depression score after treatment

Time frame: 6 month

Data from ClinicalTrials.gov

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