Treatment of Orthostatic Hypotension

NCT ID: NCT00581477

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Droxidopa

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.

Group Type: EXPERIMENTAL

Droxidopa Oral Product

Intervention Type: DRUG

Droxidopa administered in increasing dosages up to 300 mg

Interventions

Droxidopa Oral Product

Droxidopa administered in increasing dosages up to 300 mg

Intervention Type: DRUG

Other Intervention Names

L-DOPS

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Emily M. Garland

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Robertson, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P01HL056693

Identifier Type: NIH

Identifier Source: secondary_id

View Link

030750

Identifier Type: -

Identifier Source: org_study_id