NCT04782830 Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
| NCT ID | NCT04782830 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Orthostatic; Hypotension, Neurogenic |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2021-02-05 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 29 participants in total. It began in 2021-02-05 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 activity monitor to determine the amount of time patients spend in the upright position (standing and walking; upright time) during 1 week of placebo (a pill with no active ingredients) and 1 week of their regular medication for orthostatic hypotension (midodrine or atomoxetine at their usual doses). Total upright time (i.e. tolerance to standing and walking) will be compared between placebo and active treatment to test the hypothesis that it can be used to assess the efficacy of the treatment for orthostatic hypotension and whether this outcome is superior to the assessment of symptoms using validated questionnaires.
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.
Contact & Investigator
Italo Biaggioni, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT04782830 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Orthostatic; Hypotension, Neurogenic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04782830 currently recruiting?
Yes, NCT04782830 is actively recruiting participants. Contact the research team at autonomics@vumc.org for enrollment information.
Where is the NCT04782830 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT04782830 clinical trial?
NCT04782830 is sponsored by Vanderbilt University Medical Center. The principal investigator is Italo Biaggioni, MD at Vanderbilt University Medical Center. The trial plans to enroll 29 participants.