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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Seoul National University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Normalization of orthostatic bood pressure (BP) - heart rate (HR) test [ Time Frame: after 3-month medical treatment ]

Normalization of orthostatic BP-HR test after 3-month medical treatment compared to initial results.


Current Secondary Outcome:

  • 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

  • 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

  • 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.

  • 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.



Original Secondary Outcome:

  • Change of the subjective symptom survey result [ Time Frame: after 3-month medical treatment. ]
    Change of the subjective symptom survey result after 3-month medical treatment compared to initial results.
  • Change of the QOL [ Time Frame: after 3-month medical treatment. ]
    Change of the QOL after 3-month medical treatment after 3-month medical treatment compared to initial results.
  • Change of the depression score [ Time Frame: after 3-month medical treatment. ]
    Change of the depression score after 3-month medical treatment compared to initial results.


Information By: Seoul National University Hospital

Dates:
Date Received: December 2, 2014
Date Started: November 2014
Date Completion:
Last Updated: March 2, 2017
Last Verified: March 2017