350 Participants Needed

Diagnostic Testing for Postural Orthostatic Tachycardia Syndrome

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Overseen BySteve Hopkins
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand POTS, a condition that causes a significant increase in heart rate upon standing, leading to dizziness or fainting. Researchers will study individuals with POTS using various tests to gain insights into the disorder. Those who have experienced POTS symptoms for at least six months, with improvement when sitting or lying down, may qualify. The trial also seeks healthy women aged 18 to 30 without POTS symptoms for comparison. As an unphased trial, this study offers a unique opportunity to contribute to the foundational understanding of POTS and potentially enhance future treatments.

Will I have to stop taking my current medications?

The trial requires that you have a stable oral medication regimen for at least 14 days before participating. However, you must stop using certain medications like amphetamine-type stimulants, diuretics, and others listed in the exclusion criteria for specific periods before joining the study.

What prior data suggests that this diagnostic testing is safe for POTS patients?

Research on Postural Orthostatic Tachycardia Syndrome (POTS) has shown that this condition causes a fast heart rate when standing up without lowering blood pressure. This study is observational, using various tests to learn more about POTS.

As this is not a treatment trial, no new drugs or therapies are being tested, reducing concerns about side effects or treatment risks. The study aims to understand how POTS affects individuals through generally safe tests.

Previous studies on POTS have aimed to improve diagnosis and guide future treatments, demonstrating that the diagnostic methods used are well-established and safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to better understand Postural Orthostatic Tachycardia Syndrome (POTS) by comparing patients with the condition to healthy matched controls. Unlike current treatments that focus on managing symptoms with medications like beta-blockers or fludrocortisone, this study looks at phenotyping, which can uncover underlying mechanisms of the syndrome. By identifying specific characteristics and differences in patients, the trial could lead to more personalized and effective treatment approaches in the future. This exploration has the potential to transform the way POTS is diagnosed and managed, moving toward tailored therapies rather than a one-size-fits-all approach.

What evidence suggests that this multimodal diagnostic testing is effective for POTS?

Research has shown that using various tests can help doctors better identify and understand Postural Orthostatic Tachycardia Syndrome (POTS). This trial involves participants with POTS and healthy matched controls undergoing multimodal diagnostic testing. Although this study does not evaluate treatment effectiveness, gaining a deeper understanding of POTS through these methods can lead to more focused patient care. The goal is to improve POTS diagnosis, potentially leading to better management strategies for those with the condition.26789

Who Is on the Research Team?

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Steven Vernino, MD PhD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with POTS.
I am 14 or older and can agree to the study's procedures.
I have been diagnosed with POTS based on heart rate changes and symptoms.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phenotyping

Participants undergo multimodal testing to define clinical POTS classifications and phenotypic groups

2 weeks
Multiple visits for testing

Follow-up

Participants are monitored for functional and subjective changes using surveys and outcome measures

1 year
Periodic surveys and assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Multimodal Diagnostic Testing

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: POTS (Postural Orthostatic Tachycardia Syndrome)Experimental Treatment1 Intervention
Group II: Healthy matched controlsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

The evidence for treatments for postural orthostatic ...

In this systematic review, we evaluate the evidence for different treatments for POTS from 21 randomized clinical trials with 750 patients that took place ...

Diagnosis and management of postural orthostatic ...

Sustained heart rate increase of ≥ 30 beats/min (or ≥ 40 beats/min if patient is aged 12–19 yr) within 10 minutes of upright posture.

Long‐Term POTS Outcomes Survey: Diagnosis, Therapy ...

The LT‐POTS (Long Term POTS Outcomes Survey) included questions about quality of life, symptoms, therapies, education, employment, and social impact of disease.

Phenotyping of Postural Orthostatic Tachycardia Syndrome ...

This comprehensive multimodality deep phenotyping will improve the diagnostic approach, inform the development of new treatments, and allow the targeting of ...

Phenotyping of Postural Orthostatic Tachycardia Syndrome ...

This comprehensive multimodality deep phenotyping will improve the diagnostic approach, inform the development of new treatments, and allow the ...

Phenotyping of Postural Orthostatic Tachycardia Syndrome ...

This comprehensive multimodality deep phenotyping will improve the diagnostic approach, inform the development of new treatments, and allow the targeting of ...

Long‐Term POTS Outcomes Survey: Diagnosis, Therapy ...

The LT‐POTS (Long Term POTS Outcomes Survey) included questions about quality of life, symptoms, therapies, education, employment, and social impact of disease.

Postural orthostatic tachycardia syndrome (POTS): State of ...

Postural orthostatic tachycardia syndrome (POTS) is a chronic and often disabling disorder characterized by orthostatic intolerance with excessive heart rate ...

Postural Tachycardia Syndrome (POTS) Symptom Burden

This is a multi-site, baseline cohort study of individuals who met consensus criteria for the diagnosis of POTS based on clinical or laboratory ...