Brief Title
Treatment of Orthostatic Hypotension
Official Title
Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms
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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Change in Systolic Blood Pressure With Standing
Condition
Autonomic Nervous System Diseases
Intervention
Droxidopa Oral Product
Study Arms / Comparison Groups
Droxidopa
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
8
Start Date
January 2004
Completion Date
December 2020
Primary Completion Date
December 2020
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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
David Robertson, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00581477
Organization ID
030750
Secondary IDs
P01HL056693
Responsible Party
Principal Investigator
Study Sponsor
Vanderbilt University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Study Sponsor
David Robertson, MD, Principal Investigator, Vanderbilt University
Verification Date
February 2022