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Clinical Laboratory Evaluation of Chronic Autonomic Failure

NCT03648905 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 89

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Justin Y Kwan, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-06
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03648905 on ClinicalTrials.gov