6103: Norepinephrine Transporter Blockade as a Pathophysiological Biomarker in Neurogenic Orthostatic Hypotension
Status: No Longer Recruiting
Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate.
Adults with neurogenic orthostatic hypotension, ≥30 mmHg drop in SBP within 5 minutes of standing. This may include those with Multiple System Atrophy (MSA), Parkinson’s Disease (PD) and Pure Autonomic Failure (PAF).
Neurogenic orthostatic hypotension can be caused by several disorders, including pure autonomic failure, multiple system atrophy and Parkinson’s disease. Sometimes it is difficult to tell these diseases apart. The purpose of this study is to evaluate if a drug (atomoxetine) can help us to identify early on in the disease process the type of disease causing your neurogenic orthostatic hypotension. This is an investigational drug. We will use a very low dose (the one used for children) of atomoxetine and measure changes in your blood pressure. Using this drug in for this reason may give us a better way to more precisely find out what disorder you have earlier.
About this Study
This is a longitudinal observational study of participants between the ages of 18 and 80 who have neurogenic orthostatic hypotension with a drop in blood pressure (systolic – top number) of ≥30 mmHg within 5 minutes of standing.
At the screening visit, each participant will have a complete history and physical exam as well as thorough autonomic function testing. Blood pressure and heart rate will be recorded constantly during the autonomic testing – controlled breathing, deep breathing, valsalva (breathing against resistance), and cold water test. A tilt test (going from lying down position to standing while strapped safely to the bed) will be preformed to see how blood pressure and heart rate change before and after taking one pill (18 mg) of atomoxetine. Blood and urine samples will be collected and a test to determine how much the participant sweats (qsart). Several questionnaires will be given.
Every six months, each participant will get a phone call from one of the research staff to see if there have been any changes to their health.
Every year (at year 1 and 2), the participants will get a phone call and be asked to complete a questionnaire again. The questionnaire can be completed by using the internet or by paper.
At year 3, each participant will come back to the research center and have all the screening tests performed again with the exception of getting the atomoxetine test.
To be eligible to participate, you must:
- Be between the ages of 18-80 years
- Have neurogenic orthostatic hypotension, ≥30 mmHg drop in SBP within 5 minutes of standing
- Have impaired autonomic reflexes, as determined by absence of blood pressure overshoot during phase IV of the Valsalva maneuver,
- Not have any other identifiable causes of autonomic neuropathy, and
- Be able and willing to provide informed consent
You are not eligible to participate if you have:
- You are pregnant
- You have a systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies.
- You have a known intolerance to atomoxetine
- You have a pre-existing sustained severe hypertension (BP ≥ 180/110 mmHg in the sitting position)
- You are clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months.
- You have any other significant systemic, hepatic, cardiac or renal illness
- You have taken a MAO-I within 14 days
- You have closed-angle glaucoma
- You have life-threatening arrhythmias
How to participate
This study is no longer recruiting patients. To be notified of other studies, please join the Contact Registry