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Trial record 19 of 64 for:    Postural Tachycardia Syndrome

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

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ClinicalTrials.gov Identifier: NCT02171988
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Kon Chu, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Postural Orthostatic Tachycardia Syndrome Drug: Propranolol Drug: Bisoprolol Drug: Propranolol+pyridostigmine Drug: Bisoprolol+pyridostgmine Phase 4

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  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Effect of Propranolol, Bisoprolol, Pyridosgitmine in Postural Orthostatic Tachycardia Syndrome (POTS) and Prognosis After Medical Treatment
Study Start Date : March 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : December 2016


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




Primary Outcome Measures :
  1. The change of the subjective symptom survey result after 3-month medical treatment. [ Time Frame: 3 month after medical treatment ]

Secondary Outcome Measures :
  1. Normalization of orthostatic BP-HR test after 6-month medical treatment. [ Time Frame: 6 month ]
  2. The change of the subjective symptom after 6-month medical treatment. [ Time Frame: 6 month ]
  3. Change of quality of life score after treatment [ Time Frame: 6 month ]
  4. Change of depression score after treatment [ Time Frame: 6 month ]


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Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171988


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Kon Chu, MD, PhD Seoul National University Hospital

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kon Chu, MD, PhD, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02171988     History of Changes
Other Study ID Numbers: 1401091550
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Kon Chu, Seoul National University Hospital:
Postural Orthostatic Tachycardia Syndrome
propranolol
bisoprolol
pyridostigmine

Additional relevant MeSH terms:
Syndrome
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Propranolol
Bisoprolol
Pyridostigmine Bromide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Cholinesterase Inhibitors
Enzyme Inhibitors