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ACTIVE NOT RECRUITING
NCT03648905

Clinical Laboratory Evaluation of Chronic Autonomic Failure

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

OBSERVATIONAL

Enrollment

89

Start Date

2018-09-06

Completion Date

2029-12-31

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DRUG

13N-Ammonia

a perfusion imaging agent

DRUG

18F-DOPA

is a positron-emitting analog of the catechol amino acid, levodopa

DRUG

11C-Methylreboxetine (11C-MRB)

11C-MRB may be injected IV for visualizingsites of neuronal uptake of norepinephrine in the brain or periphery by PET scanning. Setup includes placement of an arm IV catheter. 11C-MRB is a Radioactive Research Drug.

DRUG

18F-Dopamine

is a positron-emitting analog of the catecholamine, dopamine

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States