Treatment of Orthostatic Hypotension

Orthostatic Hypotension Clinical Trial

Official title:

Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00581477
• Other study ID #: 030750
• Secondary ID: P01HL056693
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: January 2004
• Est. completion date: December 2020

Study information

• Verified date: February 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Dopamine Beta-Hydroxylase Deficiency
• Hypotension
• Hypotension, Orthostatic
• Nervous System Diseases
• Orthostatic Hypotension
• Orthostatic Intolerance
• Primary Dysautonomias

Intervention

Drug:
• Droxidopa Oral Product
Droxidopa administered in increasing dosages up to 300 mg

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic Blood Pressure With Standing	The difference between upright and supine systolic blood pressures (dSBP; upright - supine) was calculated for each patient at 60-240 minutes after each dose of droxidopa. For each post-dose timepoint and study day, the average of up to three blood pressure readings per droxidopa dose was calculated. Dosing is individualized for each patient based upon how well the drug is tolerated and the degree of improvement in orthostatic vital signs and symptoms following drug administration. The dosages administered, as well as the number of timepoints and days, therefore, varied between patients.	Up to 240 minutes post dose on Study Days 1, 2, 3 and 4.