Efficacy and Safety of Midodrine and Atomoxetine Treatment in Patients With Neurogenic Orthostatic Hypotension : A Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=19 patients who complained of dizziness
- •Orthostatic hypotension after 3-minute standing (systolic blood pressure drop >=20 or diastolic blood pressure drop >=10
排除标准
- •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
研究组 & 干预措施
Atomoxetine
Atomoxetine 18mg once a day.
干预措施: Atomoxetine (Drug)
Midodrine
midodrine 2.5mg twice a day (increase to 5mg three times a day if necessary)
干预措施: Midodrine (Drug)
结局指标
主要结局
Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)
时间窗: 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)
次要结局
- Change of the Depression Score (Beck Depression Inventory-II )(after 3-month medical treatment)
- Changes in Health-related Quality of Life(after 3-month medical treatment)
- Change in Orthostatic blood pressure Drop (mmHg)(after 3-month medical treatment)
研究者
Kon Chu
Professor
Seoul National University Hospital