Treatment of Orthostatic Hypotension

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Orthostatic intolerance
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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