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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Orthostatic; Hypotension, Neurogenic

Treatments: Drug: Pyridostigmine Bromide; Drug: Midodrine + pyridostigmine; Drug: Midodrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02308124

1409066609

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 3 patient groups

Midodrine

Experimental group

Description:

Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.

Treatment:

Drug: Midodrine

Pyridostigmine

Experimental group

Description:

Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.

Treatment:

Drug: Pyridostigmine Bromide

Midodrine + Pyridostigmine

Experimental group

Description:

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

Treatment:

Drug: Midodrine + pyridostigmine