Norepinephrine Transporter Blockade as a Pathological Biomarker in Neurogenic Orthostatic Hypotension
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Parkinsons Disease, Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | March 2011 |
| End Date: | March 2018 |
Norepinephrine Transporter Blockade as a Pathophysiological Biomarker in Neurogenic Orthostatic Hypotension
The autonomic or automatic nervous system helps control blood pressure. Diseases of the
autonomic nervous system may result in a drop in blood pressure on standing in many cases
leading to fainting. Diseases that affect the autonomic nervous system include pure
autonomic failure, multiple system atrophy and Parkinson's disease, and can present with
very similar symptoms and it is sometimes difficult to determine an exact diagnosis. The
purpose of the study is to find out if the blood pressure response from taking a single dose
of the medication atomoxetine can help in the diagnosis of these diseases.
autonomic nervous system may result in a drop in blood pressure on standing in many cases
leading to fainting. Diseases that affect the autonomic nervous system include pure
autonomic failure, multiple system atrophy and Parkinson's disease, and can present with
very similar symptoms and it is sometimes difficult to determine an exact diagnosis. The
purpose of the study is to find out if the blood pressure response from taking a single dose
of the medication atomoxetine can help in the diagnosis of these diseases.
This is an observational, prospective three-year longitudinal study. The investigators will
enroll participants with primary neurogenic orthostatic hypotension. All participants will
undergo an extensive neurological and cardiovascular evaluation, including detailed
autonomic testing and quality of life assessment. The investigators will then determine the
magnitude of the pressor effect produced by 18 mg atomoxetine given orally, measured 1 hour
after drug administration. Participants will be followed annually or more often if there is
a significant change in their clinical condition. During follow up at year 3, the
investigators will repeat the initial neurological, cardiovascular and autonomic evaluation.
The primary endpoint would be the final diagnosis made at year 3 after the initial
evaluation (at the end of the follow-up period) or if they develop significant worsening of
symptoms during follow-up phone assessments, based on specific clinical criteria.
enroll participants with primary neurogenic orthostatic hypotension. All participants will
undergo an extensive neurological and cardiovascular evaluation, including detailed
autonomic testing and quality of life assessment. The investigators will then determine the
magnitude of the pressor effect produced by 18 mg atomoxetine given orally, measured 1 hour
after drug administration. Participants will be followed annually or more often if there is
a significant change in their clinical condition. During follow up at year 3, the
investigators will repeat the initial neurological, cardiovascular and autonomic evaluation.
The primary endpoint would be the final diagnosis made at year 3 after the initial
evaluation (at the end of the follow-up period) or if they develop significant worsening of
symptoms during follow-up phone assessments, based on specific clinical criteria.
Inclusion Criteria:
- Age 18-80 years old with Neurogenic orthostatic hypotension, ≥30 mmHg drop in SBP
within 5 minutes of standing
- Associated with impaired autonomic reflexes, as determined by absence of blood
pressure overshoot during phase IV of the Valsalva maneuver
- Absence of other identifiable causes of autonomic neuropathy
- Able and willing to provide informed consent
Exclusion Criteria:
- Pregnancy
- Systemic illnesses known to produce autonomic neuropathy, including but not limited
to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and
autoimmune neuropathies
- Known intolerance to atomoxetine, Pre-existing sustained severe hypertension (BP at
least 180/110 mmHg in the sitting position)
- Clinically unstable coronary artery disease, or major cardiovascular or neurological
event in the past 6 months
- Any other significant systemic, hepatic, cardiac or renal illness
- Use of MAO-I within 14 days
- Known closed-angle glaucoma or Life-threatening arrhythmias
We found this trial at
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New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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