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

April 16, 2018 updated by: Kon Chu, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 83 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propranolol
Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable
Drug: Propranolol
Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable
Active Comparator: Bisoprolol
Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable
Drug: Bisoprolol
Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable
Active Comparator: Propranolol+pyridostigmine
Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.
Drug: Propranolol+pyridostigmine
Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.
Active Comparator: Bisoprolol+pyridostgmine
start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable
Drug: Bisoprolol+pyridostgmine
Start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of the subjective symptom survey result after 3-month medical treatment.
Time Frame: 3 month after medical treatment
3 month after medical treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

June 22, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401091550

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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