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NCT Number: NCT03350659

Efficacy and Safety of Midodrine and Atomoxetine for Neurogenic OH

This was a randomized, open-label clinical trial. We will enroll patients with symptomatic neurogenic OH and randomize them to 1 of 2 treatments: (1) midodrine only, (2) atomoxetine only. We will follow up patients at 1 and 3 months after treatment. If the patients meet BP criteria for OH at 1 month, they will receive combination treatment with both midodrine and atomoxetin. The primary outcome measure is amelioration of questionnaire score evaluating OH-associated symptoms at 3 months. Secondary end-points were improvement in orthostatic blood pressure (BP) drop at 1 and 3 months.

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Key information

Conditions

Neurogenic Orthostatic Hypotension Autonomic Nervous System Diseases Cardiovascular Diseases Hypotension Hypotension, Orthostatic Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

Visit 1.

  • Enroll, baseline evaluation of the patients
  • Questionnaire
  • Evaluate orthostatic hypotension symptom: Orthostatic Hypotension Questionnaire (OHQ)
  • Quality of life: Korean version of Short-form 36
  • Depressive symptom: Korean version of Beck Depression Inventory(BDI)-2
  • Blood test (6cc): ELISA for alpha 1,2 and beta 1,2 adrenergic receptor antibody and nicotinic acetylcholine receptor antibody. Preserve sample for genetic testing.
  • Randomization: randomize patients to three group in 1:1 ratio (Midodrine 5mg/day single, Atomoxetine 18mg/day single)
  • Treatment education Visit 2. 1 month after treatment Orthostatic BP check/ check drug compliance and side effect/ Questionnaire If the patients meet BP criteria for OH, initiate combination treatment (Midodrine 5mg/day+Atomoxetine 18mg/day) Visit 3. 3 months after treatment Orthostatic BP check/ check drug compliance and side effect/ Questionnaire

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >=19 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
  • Severe supine hypertension (Systolic Blood Pressure >180 or Diastolic Blood Pressure>110mmHg)
  • Pregnant women, breast-feeding
  • Unable to perform questionnaire

Treatment and study plan

Midodrine

Drug

Midodrine single 5mg/day

Other names: Midodrine only

Atomoxetine

Drug

Atomoxetine single 18mg/day

Other names: Atomoxetine only

Primary 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 (subscale OHDAS score minimal 0~ maximal 40, OHSA score minimal 0~ maximal 60)

Secondary outcomes

  1. Change in Orthostatic blood pressure Drop (mmHg)

    Time frame: after 3-month medical treatment

    Change of orthostatic Systolic blood pressure and Diastolic Blood Pressure drop after 3-month medical treatment compared to initial results.

  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: after 3-month medical 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Kyung Hee University Hospital at Gangdong

Registry information

Official study title

Efficacy and Safety of Midodrine and Atomoxetine Treatment in Patients With Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2017
Registry last updated
Apr 5, 2019

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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