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Autoimmune Investigation for POTS

N/A
Waitlist Available
Led By Luis Okamoto, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-50 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 minutes after bolus injections
Awards & highlights

Study Summary

This trial looks at whether postural tachycardia syndrome (POTS) is linked to higher levels of autoantibodies, and if these make symptoms worse.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from prolonged standing during testing; reactions at the site of blood draws; temporary changes in heart rate or blood pressure due to medication like phenylephrine or isoproterenol used during some tests; and minimal radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 minutes after bolus injections
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 minutes after bolus injections for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Autoantibody levels
Blood pressure after phenylephrine boluses
Heart rate after isoproterenol boluses
+1 more
Secondary outcome measures
Blood pressure response during phase IV of the Valsalva maneuver
Hear rate response during phase IV of the Valsalva maneuver

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autonomic and Antibody AssessmentsExperimental Treatment10 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phenylephrine
FDA approved

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,134 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
851 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
University of OklahomaOTHER
455 Previous Clinical Trials
97,552 Total Patients Enrolled
2 Trials studying Postural Orthostatic Tachycardia Syndrome
85 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Luis Okamoto, MDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

Posture study with blood samples Clinical Trial Eligibility Overview. Trial Name: NCT02725060 — N/A
Postural Orthostatic Tachycardia Syndrome Research Study Groups: Autonomic and Antibody Assessments
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Posture study with blood samples Highlights & Side Effects. Trial Name: NCT02725060 — N/A
Posture study with blood samples 2023 Treatment Timeline for Medical Study. Trial Name: NCT02725060 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled positions available in this experimental protocol?

"An investigation of clinicaltrials.gov reveals that this trial is no longer recruiting participants, despite its original posting on February 1st 2016 and most recent update on August 20th 2022. Nonetheless, there are 2113 other studies looking for patients at the present moment."

Answered by AI

What criteria must be met to qualify for this research initiative?

"This clinical trial is seeking 58 individuals with postural orthostatic tachycardia syndrome whose age falls between 18 and 50."

Answered by AI

How many participants are allowed in this research endeavor?

"This clinical trial is not currently accepting patients. The study was initially made public on February 1st 2016 and the most recent update occurred August 20th 2022. To find other studies, there are presently 28 trials for Posture-related research that require blood samples and 2085 trials specifically dealing with postural orthostatic tachycardia syndrome with open spots available."

Answered by AI

Could those aged under 80 partake in this research initiative?

"This clinical trial is looking for participants aged 18 to 50. For those younger or older than this cut-off, 444 studies exist for individuals under the age of 18 and 1603 are available for people over 65."

Answered by AI

Are there existing investigations that have incorporated both Posture analysis and blood sampling?

"In 2009, research on posture and related blood samples was conducted at Hospital de Clínicas de Porto Alegre. Since then, 125 studies have been completed while 28 are actively recruiting. In particular, Oklahoma City is hosting a significant portion of these ongoing trials."

Answered by AI

What ailments are usually evaluated with Posture study and blood sample analysis?

"Posture study with blood samples is most commonly utilized as a treatment for ocular conditions. However, it can also be prescribed to handle other illnesses like pupil dilation, catarrh and pacemaker dependency."

Answered by AI

Who else is applying?

What site did they apply to?
University of Oklahoma Health Sciences Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Autoimmune Basis for Postural Tachycardia Syndrome
Luis E Okamoto 2016. "Autoimmune Basis for Postural Tachycardia Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02725060.
All > Orthostatic Intolerance
~3 spots leftby Oct 2024
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