Treatment of Orthostatic Hypotension

Vanderbilt University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Autonomic Nervous System Diseases; Orthostatic Intolerance; Dopamine Beta-Hydroxylase Deficiency; Orthostatic Hypotension

Treatments: Drug: Droxidopa Oral Product

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00581477

030750

P01HL056693 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. The protocol includes single dose trials, dose-selection trials, 5-day trials and chronic (approximately 2 months) trials, although only dose-selection trials were consistently performed and have results presented.

Full description

We see many patients at the Autonomic Dysfunction Center who can be given a fairly definitive diagnosis, e.g., Orthostatic Intolerance, Pure Autonomic Failure, Multiple System Atrophy, and Baroreflex Failure. However, some patients present with a unique constellation of symptoms of autonomic dysfunction so that they do not fit into a diagnostic category. We hypothesize that a genetic cause exists in some of these patients. We further propose that our comprehensive evaluation of these patients will provide us with information on the pathophysiology of their condition and assist us in optimizing their treatment.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with severe orthostatic hypotension and other autonomic symptoms who do not meet criteria for one of our standard diagnoses
• non-smokers
• drug-free
• able to give informed consent
• free of pulmonary, renal, hematopoietic, hepatic and cardiac disease

Exclusion criteria

• medications affecting the autonomic nervous system
• any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic)
• anemia (Hct < 30)
• women of childbearing age who are pregnant or nursing
• smokers

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Droxidopa

Experimental group

Description:

Patients with known or suspected Dopamine beta-Hydroxylase Deficiency were administered Droxidopa doses of 25 mg, 50 mg, 100 mg, 200 mg, 250 mg or 300 mg up to three times daily. Supine and upright blood pressures were subsequently measured 60 to 240 minutes post-dose.

Treatment:

Drug: Droxidopa Oral Product