Status:
RECRUITING
Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Orthostatic; Hypotension, Neurogenic
Autonomic Failure
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
The objective of this study is to find a more objective and accurate way to assess the efficacy of the treatment for neurogenic orthostatic hypotension. For this purpose, the investigators will use an...
Detailed Description
Patients with autonomic failure cannot regulate blood pressure properly. Upon standing, their blood pressure drops (i.e. orthostatic hypotension) and may cause symptoms such as lightheadedness, dizzin...
Eligibility Criteria
Inclusion
- Male and female subjects, age 40-80 years.
- Possible or probable Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease with neurogenic orthostatic hypotension.
- Neurogenic orthostatic hypotension defined as a ≥ 30 mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
- Patients on treatment for neurogenic orthostatic hypotension with either midodrine or atomoxetine, who have experienced some improvement in their orthostatic symptoms, but still remain symptomatic (Orthostatic hypotension symptom assessment \[OHSA\] score of 1 to 5 while on medication).
- Patients who are able to stay with their caregiver during study participation.
- Able and willing to provide informed consent.
Exclusion
- Bedridden, physically disabled, or unable to walk.
- Patients with Orthostatic hypotension symptom assessment (OHSA) score ≥ 6, or orthostatic systolic blood pressure drop ≥ 30 mmHg on their regular treatment.
- Patients taking more than one medication for the treatment of neurogenic orthostatic hypotension (concomitant use of pyridostigmine or fludrocortisone are accepted).
- Pregnancy
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
- Clinically unstable coronary artery disease (recurrent angina despite medical therapy), or major cardiovascular or neurological event in the past 6 months (myocardial infarction, stroke).
- Concomitant use of anticoagulants.
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04782830
Start Date
February 5 2021
End Date
October 1 2027
Last Update
June 26 2025
Active Locations (1)
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1
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232