What side effects are associated with this type of intervention?

Common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) include medications like beta-blockers, fludrocortisone, and midodrine, which can have side effects such as fatigue, headache, and hypertension. Immunomodulatory treatments like IVIG, which are being studied for POTS, can cause side effects including infusion reactions, headache, fever, chills, and an increased risk of infections. It is important for patients to discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Postural Orthostatic Tachycardia Syndrome (POTS) mentioned in the provided context. The context does reference a trial evaluating the use of IVIG (immunomodulation) for POTS patients with evidence of autoimmunity, but it does not detail any prior FDA approvals or related drugs for this condition.

What other types of research exist?

As of 2024, promising novel alternatives to IVIG for POTS patients include the use of immunomodulatory therapies such as rituximab, which has shown efficacy in other autoimmune conditions, and cyclophosphamide, which has been used in severe cases of autoimmune diseases. Additionally, ongoing research into biologics and other targeted therapies may offer new options for POTS management.

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Immunomodulatory Agent

IVIG for POTS (iSTAND Trial)

Phase 1 & 2

Waitlist Available

Led By Steven Vernino, MD, PhD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed personal history or family history of defined autoimmune disease including Hashimoto's thyroiditis, celiac disease, antiphospholipid syndrome, rheumatoid arthritis, SLE, or Sjogren's syndrome

One or more serum autoantibodies (ANA ≥ 1:160, gAChR antibody > 0.2 nmol/L, positive ENA, aPL, TTG, gliadin) or inflammatory markers (ESR > 30, CRP > 2, low C3 complement or low immunoglobulin IgG level)

Must not have

Inadequate peripheral venous access

Current or previous immunosuppression therapy or IVIG treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13 weeks

Summary

This trial aims to see if IVIG can help people with POTS who have autoimmune issues. IVIG is a treatment made from donated blood that gives extra antibodies to help control the immune system. The study will test if this treatment can improve symptoms in these patients. IVIG has been used for over two decades to treat various autoimmune and systemic inflammatory diseases.

Who is the study for?

This trial is for adults with POTS who have moderate to severe autonomic symptoms and signs of autoimmunity, such as certain autoantibodies or a personal/family history of autoimmune diseases. Participants must be stable on current medications and able to walk. Pregnant or breastfeeding women, those with poor vein access, previous immunosuppression therapy or IVIG treatment, allergies to blood products, kidney/liver disease, recent thrombosis, or other major medical issues are excluded.

What is being tested?

The study tests if IVIG (Gamunex-C), an immune-modulating treatment, can relieve symptoms in POTS patients showing signs of autoimmunity. It compares the effects of IVIG against Albumin (a plasma protein solution) in improving patient conditions.

What are the potential side effects?

IVIG may cause side effects like headaches including migraine-like pain after infusion (aseptic meningitis), allergic reactions including skin rashes and breathing difficulties, potential hemolysis (breakdown of red blood cells), and possible kidney function impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I or someone in my family has an autoimmune disease like Hashimoto's, celiac, or rheumatoid arthritis.

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I have high levels of certain antibodies or markers indicating inflammation.

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I can walk by myself at the time of screening.

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I experience moderate to severe symptoms related to my body's automatic functions.

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I have been diagnosed with POTS.

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I have swallowing or digestion problems that have caused me to lose weight.

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My oral medication has not changed in the last 3 months.

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I am 18 or older and can give my consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have poor vein access for IVs.

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I am currently on or have had immunosuppression therapy or IVIG treatment.

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I am a premenopausal woman who is either pregnant or breastfeeding.

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My kidney or liver function tests are abnormal.

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I cannot receive treatments through IV that include immunoglobulin or albumin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Symptoms Measured by Change in COMPASS-31 Score (After Initial Treatment Phase)

Secondary study objectives

Number of Participants With Clinical Improvement

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment IVIG ArmActive Control1 Intervention

IVIG (Gammunex-C) infusion (0.4 gm/kg) every week for 4 weeks, then every 2 weeks for 8 weeks (12 weeks total).

Group II: Treatment Albumin ArmPlacebo Group1 Intervention

albumin infusion (0.4 gm/kg) every week for 4 weeks then every 2 weeks for 8 weeks (12 weeks total) during

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) include medications like beta-blockers, fludrocortisone, and midodrine, which help manage heart rate and blood pressure. Beta-blockers reduce heart rate and improve symptoms by blocking the effects of adrenaline. Fludrocortisone increases blood volume by promoting sodium retention, which helps prevent blood pressure drops upon standing. Midodrine constricts blood vessels, increasing blood pressure and reducing symptoms of dizziness and fainting. Immunomodulatory treatments like IVIG are being studied for their potential to modulate the immune system, which may be beneficial for POTS patients with autoimmune components. These treatments are crucial as they address the underlying mechanisms causing POTS symptoms, thereby improving patients' quality of life.