No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
34 (estimated)
Sponsor
Vanderbilt University Medical Center · Other
Who this trial is looking for
This trial is looking for adults with certain types of autonomic failure. Participants will take part in a screening and two testing days, lasting about 5 days in total.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 40 and 80 years old
I have been diagnosed with Multiple System Atrophy, Pure Autonomic Failure, or Parkinson disease
I have neurogenic orthostatic hypotension
I can provide informed consent
You may not be able to join if
I have high blood pressure when lying down
I am pregnant
I have diseases that cause autonomic neuropathy like diabetes
I have had recent surgery in my abdomen or pelvis
I have symptomatic hernias
I have severe gastroesophageal reflux
I have had recent fractures of my ribs or spine
I have unstable coronary artery disease or a major health event in the past 6 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to learn more about the effects of midodrine and droxidopa, two medications used for the treatment of orthostatic hypotension (low blood pressure on standing), on the veins of the abdomen of patients with autonomic failure. The study will be conducted at Vanderbilt University Medical Center, and consists of 2 parts: a screening and 2 testing days. The total length of t…
The purpose of this study is to learn more about the effects of midodrine and droxidopa, two medications used for the treatment of orthostatic hypotension (low blood pressure on standing), on the veins of the abdomen of patients with autonomic failure. The study will be conducted at Vanderbilt University Medical Center, and consists of 2 parts: a screening and 2 testing days. The total length of the study will be about 5 days. About 34 participants will be screened for the study.
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Eligibility Criteria
Inclusion Criteria:
* Male and female subjects, age 40-80 years with possible or probable Multiple System Atrophy, Pure Autonomic Failure, or Parkinson disease, as defined by Consensus Criteria.
* Neurogenic orthostatic hypotension defined as a ≥30-mmHg decrease in systolic blood pressure within 3 …
Inclusion Criteria:
* Male and female subjects, age 40-80 years with possible or probable Multiple System Atrophy, Pure Autonomic Failure, or Parkinson disease, as defined by Consensus Criteria.
* 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.
* Subjects able and willing to provide informed consent.
Exclusion Criteria:
* Supine hypertension, defined as systolic blood pressure of ≥ 160 mmHg measured on two separate occasions.
* Pregnancy.
* Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
* History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6 months.
* Symptomatic abdominal or inguinal hernias.
* Severe gastroesophageal reflux.
* Recent fractures or fissures of ribs, thoracic or lumbar spine.
* Medical devices implanted on the abdominal wall or abdomen that would interfere with the abdominal compression.
* Intolerance to any increase in intraabdominal pressure.
* Clinically unstable coronary artery disease or major cardiovascular or neurological event in the past 6 months, and other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing.
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