Postural Orthostatic Tachycardia SyndromePhase 4POTSNCT02171988
Effect of Medical Treatment and Prognosis of Postural Orthostatic Tachycardia Syndrome (POTS)
A Phase 4 study testing Propranolol, Bisoprolol and Propranolol+pyridostigmine in people with Postural Orthostatic Tachycardia Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of the study is to investigate effect of medical treatment and prognosis of Postural Orthostatic Tachycardia Syndrome (POTS) Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- Propranolol, Bisoprolol and Propranolol+pyridostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- poor drug compliance
- patients who cannot or do not want to write questionaires.
- patients who do not want draw blood
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Being tested
- Propranolol, Bisoprolol, Propranolol+pyridostigmine, Bisoprolol+pyridostgmine
- Keywords
- Postural Orthostatic Tachycardia Syndrome, propranolol, bisoprolol, pyridostigmine
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable
BisoprololDrug
Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable
Propranolol+pyridostigmineDrug
Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.
Bisoprolol+pyridostgmineDrug
Start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Active comparator | Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable Receives: Drug: Propranolol |
| Bisoprolol | Active comparator | Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable Receives: Drug: Bisoprolol |
| Propranolol+pyridostigmine | Active comparator | Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable. Receives: 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 Receives: Drug: Bisoprolol+pyridostgmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the subjective symptom survey result after 3-month medical treatment.
Measured: 3 month after medical treatment
Secondary outcomes (4)
Normalization of orthostatic BP-HR test after 6-month medical treatment.
Measured: 6 month
The change of the subjective symptom after 6-month medical treatment.
Measured: 6 month
Change of quality of life score after treatment
Measured: 6 month
Change of depression score after treatment
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postural Orthostatic Tachycardia SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kon Chu, Seoul National University Hospital
- Investigators
- Kon Chu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171988
- Sponsor's protocol ID
- 1401091550
- Acronym
- POTS
- Status last verified
- Apr 2018
- First submitted
- 19 Jun 2014
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15911704Raj 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.
PubMed 19687359Fu 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.
PubMed 21690484Kimpinski 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.
PubMed 22795533Sousa 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.
PubMed 22190289Winker 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.
PubMed 15699447Arnold 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.
PubMed 23616163Benarroch 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.
PubMed 23122672Mathias 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.
PubMed 22143364Moon 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.
PubMed 29500811
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effect of Propranolol, Bisoprolol, Pyridosgitmine in Postural Orthostatic Tachycardia Syndrome (POTS) and Prognosis After Medical Treatment
- ClinicalTrials.gov ID
- NCT02171988
- Acronym / sponsor ID
- POTS / 1401091550
- Keywords
- Postural Orthostatic Tachycardia Syndrome, propranolol, bisoprolol, pyridostigmine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Active comparator | Drug: PropranololStart propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable |
| Bisoprolol | Active comparator | Drug: BisoprololStart bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable |
| Propranolol+pyridostigmine | Active comparator | Drug: Propranolol+pyridostigmineStart propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable. |
| Bisoprolol+pyridostgmine | Active comparator | Drug: Bisoprolol+pyridostgminestart bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- poor drug compliance
- patients who cannot or do not want to write questionaires.
- patients who do not want draw blood
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololStart propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable | Drug | Propranolol |
| BisoprololStart bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable | Drug | Bisoprolol |
| Propranolol+pyridostigmineStart propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable. | Drug | Propranolol+pyridostigmine |
| Bisoprolol+pyridostgmineStart bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable | Drug | Bisoprolol+pyridostgmine |
Primary outcome
The change of the subjective symptom survey result after 3-month medical treatment.
Time frame: 3 month after medical treatment
4 secondary outcomes
Normalization of orthostatic BP-HR test after 6-month medical treatment.
Time frame: 6 month
The change of the subjective symptom after 6-month medical treatment.
Time frame: 6 month
Change of quality of life score after treatment
Time frame: 6 month
Change of depression score after treatment
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 15911704Raj 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.
- Background: PubMed 19687359Raj 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.
- Background: PubMed 21690484Fu 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.
- Background: PubMed 22795533Kimpinski 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.
- Background: PubMed 22190289Sousa 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.
- Background: PubMed 15699447Winker 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.
- Background: PubMed 23616163Arnold 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.
- Background: PubMed 23122672Benarroch 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.
- Background: PubMed 22143364Mathias 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.
- Derived from this study: PubMed 29500811Moon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kon Chu, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol, Bisoprolol and Propranolol+pyridostigmine in people with Postural Orthostatic Tachycardia Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the subjective symptom survey result after 3-month medical treatment. (time frame: 3 month after medical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02171988, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.