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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Postural Orthostatic Tachycardia Syndrome

Treatments: Drug: Propranolol; Drug: Propranolol+pyridostigmine; Drug: Bisoprolol; Drug: Bisoprolol+pyridostgmine

Study type: Interventional

Funder types: Other

Identifiers

NCT02171988

1401091550

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No 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).

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 4 patient groups

Propranolol

Active Comparator group

Description:

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

Treatment:

Drug: Propranolol

Bisoprolol

Active Comparator group

Description:

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

Treatment:

Drug: Bisoprolol

Propranolol+pyridostigmine

Active Comparator group

Description:

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

Treatment:

Drug: Propranolol+pyridostigmine

Bisoprolol+pyridostgmine

Active Comparator group

Description:

start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable

Treatment:

Drug: Bisoprolol+pyridostgmine