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

Primary Purpose

Postural Orthostatic Tachycardia Syndrome

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propranolol
Bisoprolol
Propranolol+pyridostigmine
Bisoprolol+pyridostgmine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postural Orthostatic Tachycardia Syndrome focused on measuring Postural Orthostatic Tachycardia Syndrome, propranolol, bisoprolol, pyridostigmine

Eligibility Criteria

15 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Propranolol

Bisoprolol

Propranolol+pyridostigmine

Bisoprolol+pyridostgmine

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2014
Last Updated
April 16, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02171988
Brief Title
Effect of Medical Treatment and Prognosis of Postural Orthostatic Tachycardia Syndrome (POTS)
Acronym
POTS
Official Title
Comparison of Effect of Propranolol, Bisoprolol, Pyridosgitmine in Postural Orthostatic Tachycardia Syndrome (POTS) and Prognosis After Medical Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Orthostatic Tachycardia Syndrome
Keywords
Postural Orthostatic Tachycardia Syndrome, propranolol, bisoprolol, pyridostigmine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propranolol
Arm Type
Active Comparator
Arm Description
Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable
Arm Title
Bisoprolol
Arm Type
Active Comparator
Arm Description
Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable
Arm Title
Propranolol+pyridostigmine
Arm Type
Active Comparator
Arm Description
Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.
Arm Title
Bisoprolol+pyridostgmine
Arm Type
Active Comparator
Arm Description
start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable
Intervention Type
Drug
Intervention Name(s)
Bisoprolol
Intervention Description
Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable
Intervention Type
Drug
Intervention Name(s)
Propranolol+pyridostigmine
Intervention Description
Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.
Intervention Type
Drug
Intervention Name(s)
Bisoprolol+pyridostgmine
Intervention Description
Start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable
Primary Outcome Measure Information:
Title
The change of the subjective symptom survey result after 3-month medical treatment.
Time Frame
3 month after medical treatment
Secondary Outcome Measure Information:
Title
Normalization of orthostatic BP-HR test after 6-month medical treatment.
Time Frame
6 month
Title
The change of the subjective symptom after 6-month medical treatment.
Time Frame
6 month
Title
Change of quality of life score after treatment
Time Frame
6 month
Title
Change of depression score after treatment
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kon Chu, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
15911704
Citation
Raj SR, Black BK, Biaggioni I, Harris PA, Robertson D. Acetylcholinesterase inhibition improves tachycardia in postural tachycardia syndrome. Circulation. 2005 May 31;111(21):2734-40. doi: 10.1161/CIRCULATIONAHA.104.497594. Epub 2005 May 23.
Results Reference
background
PubMed Identifier
19687359
Citation
Raj SR, Black BK, Biaggioni I, Paranjape SY, Ramirez M, Dupont WD, Robertson D. Propranolol decreases tachycardia and improves symptoms in the postural tachycardia syndrome: less is more. Circulation. 2009 Sep 1;120(9):725-34. doi: 10.1161/CIRCULATIONAHA.108.846501. Epub 2009 Aug 17.
Results Reference
background
PubMed Identifier
21690484
Citation
Fu Q, Vangundy TB, Shibata S, Auchus RJ, Williams GH, Levine BD. Exercise training versus propranolol in the treatment of the postural orthostatic tachycardia syndrome. Hypertension. 2011 Aug;58(2):167-75. doi: 10.1161/HYPERTENSIONAHA.111.172262. Epub 2011 Jun 20.
Results Reference
background
PubMed Identifier
22795533
Citation
Kimpinski K, Figueroa JJ, Singer W, Sletten DM, Iodice V, Sandroni P, Fischer PR, Opfer-Gehrking TL, Gehrking JA, Low PA. A prospective, 1-year follow-up study of postural tachycardia syndrome. Mayo Clin Proc. 2012 Aug;87(8):746-52. doi: 10.1016/j.mayocp.2012.02.020. Epub 2012 Jul 15.
Results Reference
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PubMed Identifier
22190289
Citation
Sousa A, Lebreiro A, Freitas J, Maciel MJ. Long-term follow-up of patients with postural tachycardia syndrome. Clin Auton Res. 2012 Jun;22(3):151-3. doi: 10.1007/s10286-011-0155-1. Epub 2011 Dec 22.
Results Reference
background
PubMed Identifier
15699447
Citation
Winker R, Barth A, Bidmon D, Ponocny I, Weber M, Mayr O, Robertson D, Diedrich A, Maier R, Pilger A, Haber P, Rudiger HW. Endurance exercise training in orthostatic intolerance: a randomized, controlled trial. Hypertension. 2005 Mar;45(3):391-8. doi: 10.1161/01.HYP.0000156540.25707.af. Epub 2005 Feb 7.
Results Reference
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PubMed Identifier
23616163
Citation
Arnold AC, Okamoto LE, Diedrich A, Paranjape SY, Raj SR, Biaggioni I, Gamboa A. Low-dose propranolol and exercise capacity in postural tachycardia syndrome: a randomized study. Neurology. 2013 May 21;80(21):1927-33. doi: 10.1212/WNL.0b013e318293e310. Epub 2013 Apr 24.
Results Reference
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PubMed Identifier
23122672
Citation
Benarroch EE. Postural tachycardia syndrome: a heterogeneous and multifactorial disorder. Mayo Clin Proc. 2012 Dec;87(12):1214-25. doi: 10.1016/j.mayocp.2012.08.013. Epub 2012 Nov 1.
Results Reference
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PubMed Identifier
22143364
Citation
Mathias CJ, Low DA, Iodice V, Owens AP, Kirbis M, Grahame R. Postural tachycardia syndrome--current experience and concepts. Nat Rev Neurol. 2011 Dec 6;8(1):22-34. doi: 10.1038/nrneurol.2011.187.
Results Reference
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PubMed Identifier
29500811
Citation
Moon J, Kim DY, Lee WJ, Lee HS, Lim JA, Kim TJ, Jun JS, Park B, Byun JI, Sunwoo JS, Lee ST, Jung KH, Park KI, Jung KY, Kim M, Lee SK, Chu K. Efficacy of Propranolol, Bisoprolol, and Pyridostigmine for Postural Tachycardia Syndrome: a Randomized Clinical Trial. Neurotherapeutics. 2018 Jul;15(3):785-795. doi: 10.1007/s13311-018-0612-9.
Results Reference
derived

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

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