Autoimmune Investigation for POTS

Recruiting at1 trial location

Overseen by Luis E Okamoto, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vanderbilt University Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is studying whether certain immune proteins are causing or worsening symptoms in people with POTS, a condition that makes it hard for them to stand without feeling dizzy or faint. The researchers will study people with POTS to see if these proteins are more common in those with the condition and if these levels vary.

Research Team

Luis E Okamoto, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for people aged 18-50 with Postural Tachycardia Syndrome (POTS), which causes a rapid heartbeat upon standing. Participants must have had symptoms for over 6 months and be able to follow the study's procedures. Pregnant individuals, those with recent heart issues or significant arrhythmias, liver or kidney problems, low hematocrit levels, uncontrolled hypertension, serious neurological diseases, or immune/hematological disorders cannot join.

Inclusion Criteria

I am between 18 and 50 years old.

My heart rate increases significantly when I stand up, without a drop in blood pressure, and this has been happening for more than 6 months.

The subject must understand and be able to comply with the study procedures and restrictions.

Exclusion Criteria

Pregnancy

My blood pressure is higher than 150/100 mmHg.

I have not had a heart attack, severe chest pain, serious irregular heartbeat, deep vein thrombosis, or lung blood clots in the last 6 months.

Treatment Details

Interventions

• 24-hour heart rhythm and blood pressure monitoring (Other)
• Assessment of splanchnic capacitance (Other)
• Autonomic function tests (Other)
• isoproterenol (Other)
• microneurography (Other)
• phenylephrine (Other)
• Quantitative Axonal Sudomotor Reflex Testing (Other)
• Rebreathing test (Other)

Trial Overview The study tests if autoantibodies against autonomic nervous system receptors are present in POTS patients and affect their symptoms. It includes various diagnostic tests like microneurography, blood pressure monitoring over 24 hours, posture studies with blood samples involving minimal radiation exposure, and autonomic function assessments.

Participant Groups

Group I: Autonomic and Antibody Assessments Experimental Treatment 10 Interventions

On up to 3 study days, POTS patients and control subjects will have several tests to assess autonomic function and to detect the presence of autoantibodies to adrenergic receptors. The following tests will de done but in some participants it may not be necessary to do all of them. The investigator will discuss with each participant which particular tests will be done in each particular case: * Posture study with blood samples for autoantibody testing * 24-hour heart rhythm and blood pressure monitoring * autonomic function tests * Quantitative Axonal Sudomotor Reflex Testing * Total blood volume assessment * Pharmacologic testing with phenylephrine * Pharmacologic testing with isoproterenol * Cardiac output with rebreathing * Assessment of splanchnic capacitance * Microneurography

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Dr. Scott Rollins

University of Oklahoma

Chief Executive Officer since 2016

PhD in Immunology from the University of Oklahoma

Dr. Ondria Gleason

University of Oklahoma

Chief Medical Officer

MD from the University of Oklahoma College of Medicine