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Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

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ClinicalTrials.gov Identifier: NCT02308124
Recruitment Status : Completed
First Posted : December 4, 2014
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Kon Chu, Seoul National University Hospital

Brief Summary:
Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic hypotension and investigate the quality of life of treatment of neurogenic orthostatic hypotension.

Condition or disease Intervention/treatment Phase
Orthostatic; Hypotension, Neurogenic Drug: Midodrine Drug: Pyridostigmine Bromide Drug: Midodrine + pyridostigmine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study
Study Start Date : November 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: Midodrine
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
Drug: Midodrine
Other Name: Midodrine only

Experimental: Pyridostigmine
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
Drug: Pyridostigmine Bromide
Other Name: Pyridostigmine only

Experimental: Midodrine + Pyridostigmine
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
Drug: Midodrine + pyridostigmine
Other Name: Combination




Primary Outcome Measures :
  1. Change in Orthostatic BP Drop [ Time Frame: after 3-month medical treatment ]
    Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.


Secondary Outcome Measures :
  1. Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)). [ Time Frame: after 3-month medical treatment. ]

    Change of the OH associated symptom survey result after 3-month medical treatment compared to initial results.

    OHQ questionnaire has two components: the OH daily activity scale (OHDAS), which contains 4 items measuring the impact of OH on daily activities, and the OH symptom assessment (OHSA), which contains 6 items measuring the symptoms of OH (dizziness/light headedness, vision disturbance, weakness, fatigue, trouble concentrating, and head/neck discomfort).This questionnaire reflects the severity of OH-related symptoms on a 10-point scale, with 0 indicating the absence of a symptom and 10 indicating maximal severity.

    ** OHQ total score minimal 0 ~ maximal 100


  2. Change of the Depression Score (Beck Depression Inventory-II ) [ Time Frame: after 3-month medical treatment. ]

    Change of the depression score after 3-month medical treatment compared to initial results.

    21 multiple-choice questions, each of which can be scored from 0 to 3. Higher score represent higher degree of depression.

    Score Normal; 0-13, Mild depression; 14-19, Moderate depression; 20-28, Severe depression; 29-63


  3. Changes in Health-related Quality of Life [ Time Frame: changes at 3 months after treatment ]

    changes in Short Form (36) Health Survey version 2 (SF-36v2) physical component summary scale (PCS) compared to the baseline

    SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores.


  4. Changes in Health-related Quality of Life [ Time Frame: changes at 3 months after treatment ]

    changes in Short Form (36) Health Survey version 2 (SF-36v2) mental component summary scale (MCS)

    SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age >=18 patients who complained of dizziness
  • Orthostatic hypotension after 3-minute standing (systolic blood pressure drop >=20 or diastolic blood pressure drop >=10

Exclusion Criteria:

  • Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month
  • Heart failure or Chronic renal failure
  • Patients who cannot or do not want to write questionaires.
  • Poor drug compliance

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): NCT02308124


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital

Publications:
Smith ND. Orthostatic Hypotension in the Patient with Diabetes: A Broad Review of Pharmacologic Treatment Options. Journal of Pharmacy Technology. 2013 January 1, 2013;29(1):23-34.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kon Chu, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02308124     History of Changes
Other Study ID Numbers: 1409066609
First Posted: December 4, 2014    Key Record Dates
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Hypotension, Orthostatic
Hypotension
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Midodrine
Bromides
Pyridostigmine Bromide
Anticonvulsants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents