Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02171988
Other study ID # 1401091550
Secondary ID
Status Completed
Phase Phase 4
First received June 19, 2014
Last updated April 16, 2018
Start date March 2014
Est. completion date December 2016

Study information

Verified date April 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 15 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Propranolol
Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable
Bisoprolol
Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable
Propranolol+pyridostigmine
Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.
Bisoprolol+pyridostgmine
Start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. Epub 2005 May 23. — View 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. — View 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. — View Citation

Winker R, Barth A, Bidmon D, Ponocny I, Weber M, Mayr O, Robertson D, Diedrich A, Maier R, Pilger A, Haber P, Rüdiger HW. Endurance exercise training in orthostatic intolerance: a randomized, controlled trial. Hypertension. 2005 Mar;45(3):391-8. Epub 2005 Feb 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The change of the subjective symptom survey result after 3-month medical treatment. 3 month after medical treatment
Secondary Normalization of orthostatic BP-HR test after 6-month medical treatment. 6 month
Secondary The change of the subjective symptom after 6-month medical treatment. 6 month
Secondary Change of quality of life score after treatment 6 month
Secondary Change of depression score after treatment 6 month
See also
  Status Clinical Trial Phase
Recruiting NCT05555771 - Paediatric Syncope in the Emergency Department N/A
Recruiting NCT05923840 - Chemoreflex and Baroreflex Alterations Causing Postural Tachycardia Syndrome With Orthostatic Hyperpnea and Hypocapnia N/A
Completed NCT05633407 - Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS Phase 2
Completed NCT03930914 - Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome N/A
Recruiting NCT00865917 - Cardiovascular Effects of Selective I(f)-Channel Blockade Phase 2
Recruiting NCT05741112 - The Long COVID-19 Wearable Device Study N/A
Recruiting NCT05454137 - A Shared Medical Appointment Intervention for Quality of Life Improvement in POTS N/A
Recruiting NCT05924646 - CAlgary SAlt for POTS N/A
Enrolling by invitation NCT05877534 - Effects of Individual Tailored Physical Exercise in Patients With POTS After COVID-19 - a Randomized Controlled Study N/A
Completed NCT01367977 - Head Circumference Growth in Children With Ehlers-Danlos Syndrome Who Develop Dysautonomia Later in Life
Recruiting NCT04881318 - Compression Garments in the Community With POTS N/A
Recruiting NCT06292104 - Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)
Completed NCT01547117 - Dietary Salt in Postural Tachycardia Syndrome N/A
Completed NCT01617616 - Tilt Table With Suspected Postural Orthostatic Tachycardia Syndrome (POTS) Subjects N/A
Completed NCT01563107 - Dietary Sodium's Effect on Urinary Sodium and Dopamine Excretion in Patients With Postural Tachycardia Syndrome N/A
Active, not recruiting NCT02281097 - Transdermal Vagal Stimulation for POTS N/A
Completed NCT00728026 - Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea N/A
Recruiting NCT05481177 - Ivabradine for Long-Term Effects of COVID-19 With POTS Cohort Phase 4
Not yet recruiting NCT05914649 - NC Testing in LC & POTS N/A
Completed NCT05404672 - Breathing Exercises With And Without Aerobic Training In Patients With Postural Orthostatic Tachycardia Syndrome N/A