Autonomic Nervous System DiseaseNCT00001329
Study of Norepinephrine Levels and Sympathetic Nervous System Activity
An observational study of Autonomic Nervous System Disease and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Brain and nerve cells communicate with each other by releasing and picking up chemicals called neurotransmitters. Norepinephrine is a neurotransmitter used by part of the nervous system activated during stress called the sympathetic nervous system. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Disease, Healthy, Hypertension
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1992to Sep 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Must be greater than or equal to 18 years of age.
Must not be pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Plasma Catecholamine Kinetics
Brain and nerve cells communicate with each other by releasing and picking up chemicals called neurotransmitters. Norepinephrine is a neurotransmitter used by part of the nervous system activated during stress called the sympathetic nervous system. The sympathetic nervous system is involved with regulating blood pressure and pulse rate. Researchers believe the level norepinephrine in the blood can be used to measure activity of the sympathetic nervous system.
This study is designed to answer important questions about rates of release of norepinephrine into the blood stream, removal of released norepinephrine, and the sympathetic nervous system response to stress.
Researchers will attempt to measure levels of norepinephrine and activity of the sympathetic nervous system in patients with high blood pressure, normal patients with family histories of high blood pressure, patients taking drugs that can effect levels of norepinephrine, and patients with diseases or conditions directly affecting the sympathetic nervous system.
Read the detailed description
In order to examine sympathetic nervous system function in neurocardiological disorders and catecholaminergic effects of dietary manipulations or neuropsychiatric drugs, the protocol calls for evaluations of the kinetics of 3H-norepinephrine or 3H-epinephrine in patients with hypertension, dysautonomias, or disorders thought to involve abnormal catecholaminergic function, and in normotensive normal volunteers. Apparent spillover and clearance rates are estimated based on the norepinephrine or epinephrine concentration during the infusion and their steady-state specific activities, under resting conditions and in response to physiological or pharmacological manipulations thought to affect sympathetic outflows.
- Conditions
- Autonomic Nervous System Disease, Healthy, Hypertension
- Keywords
- Yohimbine, Catecholamines, Sympathoadrenal Response, Sympathetic Nervous System, Stress, Hypertension, Autonomic Failure
- Medical subject headings
- Hypertension, Pure Autonomic Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startSep 1992
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autonomic Nervous System DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 50 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001329
- Sponsor's protocol ID
- 920259
- Other IDs
- 92-N-0259
- Status last verified
- Sep 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Goldstein DS, Horwitz D, Keiser HR, Polinsky RJ, Kopin IJ. Plasma l-[3H]norepinephrine, d-[14C]norepinephrine, and d,l-[3H]isoproterenol kinetics in essential hypertension. J Clin Invest. 1983 Nov;72(5):1748-58. doi: 10.1172/JCI111134.
PubMed 6630523Rea RF, Eckberg DL, Fritsch JM, Goldstein DS. Relation of plasma norepinephrine and sympathetic traffic during hypotension in humans. Am J Physiol. 1990 Apr;258(4 Pt 2):R982-6. doi: 10.1152/ajpregu.1990.258.4.R982.
PubMed 2331039Goldstein DS, Eisenhofer G, Stull R, Folio CJ, Keiser HR, Kopin IJ. Plasma dihydroxyphenylglycol and the intraneuronal disposition of norepinephrine in humans. J Clin Invest. 1988 Jan;81(1):213-20. doi: 10.1172/JCI113298.
PubMed 3335637
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Catecholamine Kinetics
- ClinicalTrials.gov ID
- NCT00001329
- Acronym / sponsor ID
- 920259
- Conditions
- Autonomic Nervous System Disease, Healthy, Hypertension
- Keywords
- Yohimbine, Catecholamines, Sympathoadrenal Response, Sympathetic Nervous System, Stress, Hypertension, Autonomic Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Sep 1992
- Study completion
- Sep 2002
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brain and nerve cells communicate with each other by releasing and picking up chemicals called neurotransmitters. Norepinephrine is a neurotransmitter used by part of the nervous system activated during stress called the sympathetic nervous system. The sympathetic nervous system is involved with regulating blood pressure and pulse rate. Researchers believe the level norepinephrine in the blood can be used to measure activity of the sympathetic nervous system.
This study is designed to answer important questions about rates of release of norepinephrine into the blood stream, removal of released norepinephrine, and the sympathetic nervous system response to stress.
Researchers will attempt to measure levels of norepinephrine and activity of the sympathetic nervous system in patients with high blood pressure, normal patients with family histories of high blood pressure, patients taking drugs that can effect levels of norepinephrine, and patients with diseases or conditions directly affecting the sympathetic nervous system.
Detailed description
In order to examine sympathetic nervous system function in neurocardiological disorders and catecholaminergic effects of dietary manipulations or neuropsychiatric drugs, the protocol calls for evaluations of the kinetics of 3H-norepinephrine or 3H-epinephrine in patients with hypertension, dysautonomias, or disorders thought to involve abnormal catecholaminergic function, and in normotensive normal volunteers. Apparent spillover and clearance rates are estimated based on the norepinephrine or epinephrine concentration during the infusion and their steady-state specific activities, under resting conditions and in response to physiological or pharmacological manipulations thought to affect sympathetic outflows.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 6630523Goldstein DS, Horwitz D, Keiser HR, Polinsky RJ, Kopin IJ. Plasma l-[3H]norepinephrine, d-[14C]norepinephrine, and d,l-[3H]isoproterenol kinetics in essential hypertension. J Clin Invest. 1983 Nov;72(5):1748-58. doi: 10.1172/JCI111134.
- Background: PubMed 2331039Rea RF, Eckberg DL, Fritsch JM, Goldstein DS. Relation of plasma norepinephrine and sympathetic traffic during hypotension in humans. Am J Physiol. 1990 Apr;258(4 Pt 2):R982-6. doi: 10.1152/ajpregu.1990.258.4.R982.
- Background: PubMed 3335637Goldstein DS, Eisenhofer G, Stull R, Folio CJ, Keiser HR, Kopin IJ. Plasma dihydroxyphenylglycol and the intraneuronal disposition of norepinephrine in humans. J Clin Invest. 1988 Jan;81(1):213-20. doi: 10.1172/JCI113298.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Nervous System Disease and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001329, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.