Clinical trial NCT02308124: Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study
Official title: Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Orthostatic; Hypotension, Neurogenic
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility 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

Primary outcomes:
measure: Change in Orthostatic BP Drop
timeFrame: after 3-month medical treatment
Secondary outcomes:
measure: Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).
timeFrame: after 3-month medical treatment.
measure: Change of the Depression Score (Beck Depression Inventory-II )
timeFrame: after 3-month medical treatment.
measure: Short-form 36 Version 2
timeFrame: changes at 3 months after treatment
measure: Changes in Health-related Quality of Life
timeFrame: changes at 3 months after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital, Seoul, South Korea
name: Kon Chu
role: PRINCIPAL_INVESTIGATOR
References:
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