NCT02171988

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

June 19, 2014

Last Update Submit

April 16, 2018

Conditions

Postural Orthostatic Tachycardia Syndrome

Keywords

Postural Orthostatic Tachycardia Syndromepropranololbisoprololpyridostigmine

Outcome Measures

Primary Outcomes (1)

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

    3 month after medical treatment

Secondary Outcomes (4)

  • 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 treatment

    6 month

  • Change of depression score after treatment

    6 month

Study Arms (4)

Propranolol

ACTIVE COMPARATOR

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

Drug: Propranolol

Bisoprolol

ACTIVE COMPARATOR

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

Drug: Bisoprolol

Propranolol+pyridostigmine

ACTIVE COMPARATOR

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

Drug: Propranolol+pyridostigmine

Bisoprolol+pyridostgmine

ACTIVE COMPARATOR

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

Drug: Bisoprolol+pyridostgmine

Interventions

PropranololDRUG

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

Propranolol
BisoprololDRUG

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

Bisoprolol
Propranolol+pyridostigmineDRUG

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

Propranolol+pyridostigmine
Bisoprolol+pyridostgmineDRUG

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

Bisoprolol+pyridostgmine

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (10)

  • 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.

    PMID: 15911704BACKGROUND

  • 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.

    PMID: 19687359BACKGROUND

  • 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.

    PMID: 21690484BACKGROUND

  • 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.

    PMID: 22795533BACKGROUND

  • 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.

    PMID: 22190289BACKGROUND

  • 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.

    PMID: 15699447BACKGROUND

  • 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.

    PMID: 23616163BACKGROUND

  • 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.

    PMID: 23122672BACKGROUND

  • 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.

    PMID: 22143364BACKGROUND

  • 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.

    PMID: 29500811DERIVED

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

PropranololBisoprolol

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Kon Chu, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, professor

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 24, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2016

Study Completion

December 1, 2016

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

KR(1)