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

Phase 4

Completed

• Conditions: Orthostatic; Hypotension, Neurogenic
• Interventions: Drug: Midodrine + pyridostigmine; Drug: Midodrine; Drug: Pyridostigmine Bromide

• Registration Number: NCT02308124
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-04
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2017-01-04
• Results First Submitted QC: 2017-03-02
• Results First Posted: 2017-04-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midodrine + Pyridostigmine	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.
Midodrine	Midodrine	Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
Pyridostigmine	Pyridostigmine Bromide	Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.

Primary Outcome Measures

Name	Time	Method
Change in Orthostatic BP Drop	after 3-month medical treatment	Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.

Secondary Outcome Measures

Name	Time	Method
Changes in Health-related Quality of Life	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.
Change of the Depression Score (Beck Depression Inventory-II )	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
Short-form 36 Version 2	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.
Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of