Health TrialsbyHealthPanel

POTS Adrenergic Ab (CIHR Aims #1&2)

ConditionPostural Tachycardia Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorUniversity of Calgary

About this trial

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 adrenergic receptors compared with control subjects without POTS.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients who have been previously diagnosed with POTS

Control subjects (patients not diagnosed with POTS)

Age between 18 - 60 years

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

Disqualifiers

Smokers

Overt cause for postural tachycardia, i.e., acute dehydration

Significant cardiovascular, pulmonary, hepatic, or hematological disease by history or prior testing

Highly trained athletes

Trial population

Patients with POstural Tachycardia Syndrome (POTS)

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Phenylephrine

    Drug

    incremental small doses of IV phenylephrine to find the dose that transiently raises systolic blood pressure by 25 mmHg

  • Isoproterenol

    Drug

    incremental small doses of IV isoproterenol to find the dose that transiently raises heart rate by 25 bpm

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: Postural Tachycardia Syndrome (POTS)2 interventions
Group B: Healthy (control) Subjects2 interventions

Trial outcomes

Primary outcomes

1

The proportion of alpha-1 Ab titer positive subjects

The primary comparison will be the proportion of Ab titers between POTS patients compared to control subjects.

Time frame
1 Year (to measure Adrenergic antibody assay)

Secondary outcomes

1

Antibody Positivity by Joint Hypermobility Status

These comparisons include proportions of POTS patients with +va adrenergic Ab with a co-diagnosis of joint hypermobility syndrome (EDS III) vs without joint hypermobility syndrome (EDS III).

Time frame
1 Year (to measure Adrenergic antibody assay)
2

Antibody Positivity by Clinical Autoimmune Syndromes

These comparisons include proportions of POTS patients with +ve adrenergic Ab with a co-diagnosis of a clinical autoimmune disorder vs without a clinical autoimmune disorder.

Time frame
1 Year (to measure Adrenergic antibody assay)
3

Antibody Positivity by Viral Onset of POTS

These comparisons include proportions of POTS patients with +ve adrenergic Ab with a viral onset to their POTS vs without a viral onset to their POTS.

Time frame
1 Year (to measure Adrenergic Antibody assay)
4

Isoproterenol HR Increase (PD25)

A comparison of the dose of isoproterenol required to acutely increase the Heart Rate by 25 bpm from a pre-injection baseline (as a measure of beta-receptor sensitivity) in antibody positive vs. antibody negative subjects.

Time frame
1 Year (to measure Adrenergic Antibody assay)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov
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