Clinical trial NCT00581477: Treatment of Orthostatic Hypotension
Official title: Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Autonomic Nervous System Diseases
Orthostatic Hypotension
Dopamine Beta-Hydroxylase Deficiency
Orthostatic Intolerance
Keywords: autonomic nervous system diseases
blood pressure
congenital
orthostasis
catecholamines
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-12-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Although the study was designed as a potential trial of multiple medications, plus placebo, in actuality it served as a means of safely determining the optimal dose of Droxidopa for our patients with Dopamine beta-Hydroxylase Deficiency to take at home. Before each dose of Droxidopa, blood pressure and heart rate were measured for 30 minutes. At 60 or 120 minutes after dosing, blood pressure was also measured after 5 minutes of lying down and 5 minutes of sitting or standing. These measurements were used to calculate the orthostatic change in systolic blood pressure, the primary outcome.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Systolic Blood Pressure With Standing
timeFrame: Up to 240 minutes post dose on Study Days 1, 2, 3 and 4.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: David Robertson, MD
role: PRINCIPAL_INVESTIGATOR
References: