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Norepinephrine Transporter Blockade as a Pathological Biomarker in Neurogenic Orthostatic Hypotension (6103)
This study has been completed.
Sponsor:
Vanderbilt University Medical Center
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01316666
First received: March 15, 2011
Last updated: January 4, 2017
Last verified: January 2017
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Purpose
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.
| Condition |
|---|
| Orthostatic Hypotension Pure Autonomic Failure Multiple System Atrophy Parkinson's Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Norepinephrine Transporter Blockade as a Pathophysiological Biomarker in Neurogenic Orthostatic Hypotension |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Primary Orthostatic Hypotension
Multiple System Atrophy
Pure Autonomic Failure
U.S. FDA Resources
Further study details as provided by Italo Biaggioni, Vanderbilt University:
Primary Outcome Measures:
- Final Diagnosis (pre vs post ganglionic autonomic failure) based on clinical criteria. [ Time Frame: 3 years ]
Probable MSA - PAF with urinary incontinence or an orthostatic decrease of 30 mmHG in systolic blood pressure within 3 minutes of standing and poorly levodopa responsive parkinsonism or a cerebellar syndome.
For Possible MSA - parkinsonism or a cerebellar syndrome and one additional feature.
Probable PAF - orthostatic hypotension and impaired autonomic reflexes in the absence of clinical signs or symptoms of neurodegeneration.
For Parkinson's Disease: diagnosed based on the United Kingdom Parkinson Disease Society Brain Bank clinical diagnostic criteria.
| Enrollment: | 50 |
| Study Start Date: | March 2011 |
| Study Completion Date: | December 2016 |
| Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Neurogenic Hypotension
Patients with neurogenic hypotension, which includes those with Pure Autonomic Failure (PAF), Multiple System Atrophy (MSA) and Parkinson Disease (PD)
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
participants with neurogenic orthostatic hypotension, which is a drop in systolic blood pressure of at least 30 mmHg within 5 minutes of standing with associated impaired autonomic reflexes.
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01316666
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316666
Locations
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center (Harvard) | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55902 | |
| United States, New York | |
| New York University | |
| New York, New York, United States, 10016 | |
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
| Principal Investigator: | Italo Biaggioni, MD | Vanderbilt University |
More Information
Additional Information:
Publications:
| Responsible Party: | Italo Biaggioni, MD, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01316666 History of Changes |
| Other Study ID Numbers: |
101311 U54NS065736 ( U.S. NIH Grant/Contract ) |
| Study First Received: | March 15, 2011 |
| Last Updated: | January 4, 2017 |
Keywords provided by Italo Biaggioni, Vanderbilt University:
|
orthostatic hypotension Multiple System Atrophy Pure Autonomic Failure Parkinson's Disease |
Additional relevant MeSH terms:
|
Parkinson Disease Atrophy Hypotension Hypotension, Orthostatic Multiple System Atrophy Shy-Drager Syndrome Pure Autonomic Failure Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Pathological Conditions, Anatomical |
Vascular Diseases Cardiovascular Diseases Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Norepinephrine Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on July 26, 2017