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NCT Number: NCT02308124

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

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.

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Key information

Conditions

Orthostatic; Hypotension, Neurogenic Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

In patients with neurogenic orthostatic hypotension, the appropriate treatment was identified by comparing the treatment effects and side effects for each treatment drug. In addition, by confirming the effect of orthostatic hypotension on lowering the quality of life, it is expected that the improvement of the quality of life will help.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midodrine

Drug

Other names: Midodrine only

Pyridostigmine Bromide

Drug

Other names: Pyridostigmine only

Midodrine + pyridostigmine

Drug

Other names: Combination

Primary outcomes

  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 outcomes

  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. Short-form 36 Version 2

    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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2014
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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