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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02171988
Acronym
POTS
Enrollment
150
Registered
2014-06-24
Start date
2014-03-31
Completion date
2016-12-31
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Keywords

Postural Orthostatic Tachycardia Syndrome, propranolol, bisoprolol, pyridostigmine

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.

Interventions

DRUGBisoprolol+pyridostgmine

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

DRUGPropranolol

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

DRUGBisoprolol

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

DRUGPropranolol+pyridostigmine

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime 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 treatment6 month
Change of depression score after treatment6 month

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026