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Completed

NCT Number: NCT02171988

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

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

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Key information

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propranolol

Drug

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

Bisoprolol

Drug

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

Propranolol+pyridostigmine

Drug

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

Bisoprolol+pyridostgmine

Drug

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

Primary outcomes

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

    Time frame: 3 month after medical treatment

Secondary outcomes

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

    Time frame: 6 month

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

    Time frame: 6 month

  3. Change of quality of life score after treatment

    Time frame: 6 month

  4. Change of depression score after treatment

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: POTS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2014
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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