Postural Tachycardia Syndrome Clinical Trial
Official title:
The Pathophysiological Role of Adrenergic Antibodies in Postural Tachycardia Syndrome (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 adrenergic receptors compared with control subjects without POTS.
Status | Recruiting |
Enrollment | 125 |
Est. completion date | December 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - 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) - Able and willing to provide consent Exclusion Criteria: - 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 - Subjects with somatization or severe anxiety symptoms will be excluded - Use of drospirenone (a spironolactone analogue) containing oral contraceptive agent - Hypertension defined as supine resting BP>145/95 mmHg off medications or needing antihypertensive medication - Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule - Unable to give informed consent |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 Year (to measure Adrenergic antibody assay) | |
Secondary | 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). | 1 Year (to measure Adrenergic antibody assay) | |
Secondary | 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. | 1 Year (to measure Adrenergic antibody assay) | |
Secondary | 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. | 1 Year (to measure Adrenergic Antibody assay) | |
Secondary | 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. | 1 Year (to measure Adrenergic Antibody assay) | |
Secondary | Phenylephrine Systolic BP Increase (PD25) | A comparison of the dose of phenylephrine required to acutely increase the Systolic Blood Pressure by 25 mmHg from a pre-injection baseline (as a measure of alpha-receptor sensitivity) in antibody positive vs. antibody negative subjects. | 1 Year (to measure Adrenergic Antibody assay) | |
Secondary | The proportion of beta adrenergic Ab titer positive subjects | The primary comparison will be the proportion of Ab titers between POTS patients | 1 Year (to measure Adrenergic Antibody assay) |
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