Neurogenic Orthostatic Hypotension Clinical Trial
Official title:
Efficacy and Safety of Midodrine and Atomoxetine Treatment in Patients With Neurogenic Orthostatic Hypotension : A Prospective Randomized Study
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.
Visit 1.
1. Enroll, baseline evaluation of the patients
2. 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
3. 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.
4. Randomization: randomize patients to three group in 1:1 ratio (Midodrine 5mg/day single,
Atomoxetine 18mg/day single)
5. 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
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