Active — Not RecruitingNot Applicable

Clinical Laboratory Evaluation of Chronic Autonomic Failure

United States89 participantsStarted 2018-09-06

Plain-language 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.

Who can participate

Age range18 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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 into this 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 or pre- or post-bilateral endosco…

What they're measuring

Results of clinical laboratory research tests

Timeframe: Initial Visit and on an approximately biennial basis

Trial details

NCT IDNCT03648905

SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2028-12-31