Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Mar 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to measure how well treatments work for people with neurogenic orthostatic hypotension, a condition where standing up can cause a significant drop in blood pressure, leading to dizziness or fainting. Researchers will use a small activity monitor, similar to a fitness tracker, to see how much time participants spend standing or walking during one week on a placebo (a pill with no medicine) and one week on their usual medication (either midodrine or atomoxetine). The goal is to find out if this method gives more accurate results than traditional questionnaires that ask about symptoms.

To be eligible for this study, participants should be between 40 and 80 years old and have a specific type of neurogenic orthostatic hypotension, which has been diagnosed by a doctor. They should also be currently taking medication for their condition and still have some symptoms. It's important that participants are able to walk and have someone to help them during the study. Those who are bedridden, have more severe symptoms, or have certain other medical conditions may not qualify. If you join the study, you’ll wear the activity monitor and continue your usual treatment while helping researchers learn more about this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.