Adrenergic Antibodies for POTS

Overseen By Robert S Sheldon, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Drospirenone, Antihypertensives

Disqualifiers: Smokers, Cardiovascular disease, Anxiety, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a potential link between certain antibodies (proteins made by the immune system) and Postural Tachycardia Syndrome (POTS), a condition that causes increased heart rate when standing. The researchers aim to determine if people with POTS have more of these particular antibodies, known as POTS Adrenergic Ab, compared to those without the condition. Participants will receive two specific medications, phenylephrine and isoproterenol, through an IV. Ideal participants are those diagnosed with POTS who experience symptoms like rapid heart rate upon standing. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could provide new insights into POTS.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using drospirenone-containing oral contraceptives or need antihypertensive medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that treatments for Postural Orthostatic Tachycardia Syndrome (POTS) aim to manage symptoms like a fast heartbeat when standing up. Specific safety information for the new POTS Adrenergic Ab treatment is not yet available, but knowing the trial phase can help. This pilot study is in the early stages of testing. Early trials primarily focus on assessing the treatment's safety and tolerability.

Prospective participants should know that early studies usually involve small groups, allowing for close monitoring of any side effects. Participants report how they feel after receiving the treatment, and doctors track any negative reactions. This process helps determine if the treatment is safe for broader use.

In summary, while exact safety details for POTS Adrenergic Ab are not yet available, early trials are designed to ensure treatments are safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Postural Tachycardia Syndrome (POTS) focus on managing symptoms using medications like beta-blockers or fludrocortisone, which aim to control heart rate and blood volume. But the POTS Adrenergic Ab treatment stands out by targeting adrenergic antibodies, potentially addressing a root cause of the condition rather than just its symptoms. Researchers are excited about this approach because it could offer more precise symptom control and improve the quality of life for those with POTS. This treatment could pave the way for a more tailored approach, reducing reliance on broader medications that can have varied side effects.

What evidence suggests that this treatment might be an effective treatment for POTS?

Studies have shown that people with POTS (postural orthostatic tachycardia syndrome) often have antibodies affecting adrenergic receptors, which help control heart rate and blood pressure. Research suggests these antibodies might cause some POTS symptoms, such as a faster heart rate when standing. One study found that people with POTS had noticeable differences in blood vessel function compared to healthy individuals. This trial will compare POTS patients with healthy control subjects to further investigate these differences. The findings suggest that targeting these antibodies could effectively treat POTS symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

Satish R Raj, MD, MSCI

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients who have been previously diagnosed with POTS

Control subjects (patients not diagnosed with POTS)

Males and Females (Give that >80% of POTS patients are female, we will attempt to enroll a similar percentage of female control subjects)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a series of injections of phenylephrine and isoproterenol while monitoring heart rate and blood pressure

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• POTS Adrenergic Ab

How Is the Trial Designed?

Group I: Postural Tachycardia Syndrome (POTS) Experimental Treatment 2 Interventions

Patients with postural tachycardia syndrome; patients will receive both IV phenylephrine and IV isoproterenol

Group II: Healthy (control) Subjects Experimental Treatment 2 Interventions

Healthy volunteers that are gender and age-matched (by groups) to the POTS patients; healthy subjects will receive both IV phenylephrine and IV isoproterenol

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02673996

NCT02673996 | POTS Adrenergic Ab (CIHR Aims #1&2) Objective: In this pilot study, we will test the hypothesis that patients with POTS (age 18-60 years) will have a higher percentage of functional antibodies to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11292765/

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.

3. jacc.org jacc.org/doi/10.1016/j.jacc.2018.11.059

Postural Orthostatic Tachycardia Syndrome Specific data supporting psychological therapy in POTS are lacking, but there is a 2016 case report demonstrating significant decrease in POTS ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1050173825000933

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 ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.113.000755?doi=10.1161/JAHA.113.000755

Autoimmune Basis for Postural Tachycardia Syndrome The sera of all 14 POTS patients demonstrated significant arteriolar contractile activity (69±3% compared to 91±1% of baseline for healthy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6113123/

Postural Tachycardia Syndrome – Diagnosis, Physiology, and ... POTS is clinically characterized by sustained excessive tachycardia upon standing that occurs in the absence of significant orthostatic hypotension and other ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1566070221000588

Postural orthostatic tachycardia syndrome (POTS): State of ... POTS is a chronic and often disabling disorder characterized by orthostatic intolerance with excessive heart rate increase without hypotension during upright ...

8. ccjm.org ccjm.org/content/86/5/333

Evaluating and managing postural tachycardia syndrome Upon passive head-up tilting, the heart rate increases in POTS by at least 30 bpm but remains largely stable in healthy individuals.