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Protocol Details

Clinical Laboratory Evaluation of Chronic Autonomic Failure

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-N-0140

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Autonomic Failure;
Parkinson's Disease;
Pure Autonomic Failure;
Multiple System Atrophy;
Lewy Body;
Catecholamines

Recruitment Keyword(s)

None

Condition(s)

Parkinson's Disease;
Multiple System Atrophy;
Autonomic Failure

Investigational Drug(s)

18F-Dopamine
13N-Ammonia
18F-DOPA

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

The autonomic nervous system controls automatic body functions. Researchers want to improve the tests used to diagnose autonomic failure. Orthostatic hypertension is a drop in blood pressure when a person stands up. Researchers want to focus on this sign of autonomic failure.

Objective:

To improve testing for conditions that cause autonomic nervous system failure.

Eligibility:

People ages 18 and older in one of these categories:

-Their blood pressure drops when they get up.

-They have had a heart transplant or bilateral endoscopic thoracic sympathectomies or have had or will have renal sympathetic ablation

Design:

All participants will be screened with:

-Medical history

-Physical exam

-Blood and urine tests

Some participants will be screened with:

-Heart and breathing tests

-IV placement into an arm vein

-Tilt table testing: Participants lie on a table that tilts while an IV is used to draw their blood.

Participants may stay in the hospital for up to 1 week depending on their tests. Tests may include repeats of screening tests and:

-Sweat testing: A drug is placed on the skin to cause sweating. Sensors on the skin measure moisture.

-Lumbar puncture: A needle is inserted between the bones in the back to collect fluid.

-MRI and PET/CT scan: Participants lie on a table that slides into a scanner. For the PET/CT, a small amount of a radioactive chemical will be injected with a small amount of a radioactive chemical.

-Bladder catheter placement to collect urine

-Skin biopsies: A punch tool removes a small skin sample.

-Tests to see how the pupils react to light

-Smelling tests

-Thinking and memory tests

-Questionnaires

Participants may have a visit about 2 years later to repeat tests.

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Eligibility

INCLUSION CRITIERIA:

Inclusion Critieria: Patients referred for orthostatic hypotension. This is the main subject cohort.

- Previously studied and diagnosed with one of the forms of nOH or else newly accrued with a referral diagnosis of orthostatic hypotension, and

- 18 years or older, and

- Able to provide own consent to participate or have an existing Legally Authorized Representative (LAR).

If a patient has already been diagnosed as having neurodegenerative CAF under NIH Clinical Protocol 03-N-0004, this satisfies the inclusion criteria for that patient. Previous enrollment in NIH Clinical Protocol 03-N-0004 is not required for enrollment in this study. We do plan to recruit participation intothis study from NIH Clinical Protocol 03-N-0004 which has been closed.

If a patient has been referred for OH, then the patient gives consent at the NIH Clinical Center (and therefore is accrued) and then has screening testing at the NIH Clinical Center to confirm that the OH is neurogenic. We anticipate that all patients referred for OH will be shown to have nOH upon screening testing at the NIH Clinical Center. At the time of screening, exclusionary abnormal laboratory test results (e.g., high serum creatinine indicating renal failure) may come to light, in which case they will be withdrawn from the study; however, the patient would have been accrued.

Inclusion criteria: Control patients with iatrogenic CAF

- Patients with heart transplants, pre or post bilateral endoscopic thoracic sympathectomies, or pre or post-renal sympathetic ablation, and

- 18 years or older, and

- Able to provide own consent to participate.

Inclusion criteria: Cotrol patients with PD No OH:

-Patients with PD and no OH who have (a) already been evaluated under other protocols of the AMS and are undergoing follow-up; (b) have already been evaluated under another intramural NINDS protocol; or (c) have cardiac symptoms, signs, or laboratory findings that in the opinion of the PI make it likely there is a cardiac

sympathetic lesion, and

-18 years or older, and

-Able to provide own consent to participate.

Inclusion criteria: Healthy Volunteers:

- Age 18 years or older and

- Able to provide own informed consent to participate

NIH employees may participate. There is no direct solicitation of employees/staff by supervisors. Co-workers will not solicit co-workers. NIH employees are required to abide by NIH Policy Manual 2300-630-3, Leave Policy for NIH Employees Participating in

NIH Medical Research Studies.

EXCLUSION CRITIERIA:

Patient Group Referred for Orthostatic Hypotension

- A medical condition that in the judgment of the Principal Investigator would place the subject at substantially increased acute medical risk, or

- A disqualifying condition such as: hepatic or renal failure, symptomatic congestive heart failure, severe anemia, psychosis, refractory ventricular arrhythmias, currently symptomatic coronary heart disease, cerebrovascular disease with current symptoms (e.g., recent transient ischemic attacks), diabetes or

- Secondary form of CAF, such as diabetic autonomic neuropathy, or

- Being treated currently (within 2 weeks of anticipated protocol participation) with a medication known to interfere with the cell membrane norepinephrine transporter, which would obviate obtaining scientifically valid results (e.g., tricyclic antidepressant).

- Condition that may cause difficulty or inability to insert a catheter into a vein, or

- Unable to tolerate lying still for up to 1 hour during the procedures, or

- Refusal to undergo certain procedures. These include: (1) IV catheter and blood drawing; (2) DNA extraction, storage, and analysis; (3) PET scanning; and (4) skin biopsies, or

- History of keloid, or

- Unable to travel safely to the NIH CC, or

- Lacking consent capacity, unless a Durable Power of Attorney (DPA) is in place.

- Subordinates of study investigators or relatives of the PI or AIs.

Patient Control Group with Iatrogenic CAF or PD no OH

- A medical condition which in the judgment of the Principal Investigator would place the subject at substantially increased acute medical risk, or

- A disqualifying condition such as: hepatic or renal failure, symptomatic congestive heart failure, severe anemia, psychosis, refractory ventricular arrhythmias, currently symptomatic coronary heart disease, cerebrovascular disease with current symptoms (e.g., recent transient ischemic attacks), or diabetes or

- Being treated currently (within 2 weeks of anticipated protocol participation) with a medication that would obviate obtaining scientifically valid results (e.g., tricyclic antidepressant).

- Condition that may cause difficulty or inability to insert a catheter into a vein, or

- Unable to tolerate lying still for up to 1 hour during the procedures, or

- Refusal to undergo certain procedures. These include: (1) IV catheter and (2) PET scanning, or

- Unable to travel safely to the NIH CC, or

- Lacking consent capacity, or

- Subordinates of study investigators or relatives of the PI or AIs.

Healthy Volunteer Group

- A medical condition which in the judgment of the Principal Investigator would place the subject at substantially increased acute medical risk, or

- A disqualifying condition such as: hepatic or renal failure, symptomatic congestive heart failure, severe anemia, psychosis, refractory ventricular arrhythmias, currently symptomatic coronary heart disease, cerebrovascular disease with current symptoms (e.g., recent transient ischemic attacks), diabetes or

- Being treated currently (within 2 weeks of anticipated protocol participation) with a medication that would obviate obtaining scientifically valid results (e.g., tricyclic antidepressant).

- Condition that may cause difficulty or inability to insert a catheter into a vein, or

- Unable to tolerate lying still for up to 1 hour during the procedures, or

- Refusal to undergo certain procedures. These include: (1) IV catheter and (2) PET scanning, or

- Unable to travel safely to the NIH CC, or

- Lacking consent capacity, or

- Subordinates of study investigators or relatives of the PI or AIs.


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Citations:

Goldstein DS, Sharabi Y. Neurogenic orthostatic hypotension: a pathophysiological approach. Circulation. 2009 Jan 6;119(1):139-46. doi: 10.1161/CIRCULATIONAHA.108.805887.

Jain S, Goldstein DS. Cardiovascular dysautonomia in Parkinson disease: from pathophysiology to pathogenesis. Neurobiol Dis. 2012 Jun;46(3):572-80. doi: 10.1016/j.nbd.2011.10.025. Epub 2011 Nov 4.

Goldstein DS, Holmes C, Kopin IJ, Sharabi Y. Intra-neuronal vesicular uptake of catecholamines is decreased in patients with Lewy body diseases. J Clin Invest. 2011 Aug;121(8):3320-30. doi: 10.1172/JCI45803. Epub 2011 Jul 25.

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Contacts:

Principal Investigator

Referral Contact

For more information:

David S. Goldstein, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Janna Gelsomino, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7-5653
10 Center Drive
Bethesda, Maryland 20892
(301) 435-5166
janna.gelsomino@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03648905

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