POTS Adrenergic Ab (CIHR Aims #1&2)

NCT02673996 | Recruiting

• 2 other identifiers: REB15-2434MOP142426
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postural Tachycardia Syndrome

Keywords

antibody; autoimmune; adrenergic; autonomic

Outcome Measures

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.

  1 Year (to measure Adrenergic antibody assay)

Secondary Outcomes (6)

• Antibody Positivity by Joint Hypermobility Status

  1 Year (to measure Adrenergic antibody assay)

• Antibody Positivity by Clinical Autoimmune Syndromes

  1 Year (to measure Adrenergic antibody assay)

• Antibody Positivity by Viral Onset of POTS

  1 Year (to measure Adrenergic Antibody assay)

• Isoproterenol HR Increase (PD25)

  1 Year (to measure Adrenergic Antibody assay)

• Phenylephrine Systolic BP Increase (PD25)

  1 Year (to measure Adrenergic Antibody assay)

Study Arms (2)

Postural Tachycardia Syndrome (POTS)

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

Drug: Phenylephrine; Drug: Isoproterenol

Healthy (control) Subjects

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

Drug: Phenylephrine; Drug: Isoproterenol

Interventions

Phenylephrine DRUG

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

Also known as: NeoSynephrine

Healthy (control) Subjects; Postural Tachycardia Syndrome (POTS)

Isoproterenol DRUG

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

Also known as: Isuprel

Healthy (control) Subjects; Postural Tachycardia Syndrome (POTS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with POstural Tachycardia Syndrome (POTS)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum for antibody assay; plasma for cytokine assessment; plasma for catecholamines

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Phenylephrine; Isoproterenol

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Satish R Raj, MD, MSCI

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish R Raj, MD, MSCI

CONTACT

403-210-6152; autonomic.research@ucalgary.ca

Robert S Sheldon, MD, PhD

CONTACT

403-220-8191; autonomic.research@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 4, 2016
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)