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POTS Adrenergic Ab (CIHR Aims #1&2)

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ClinicalTrials.gov Identifier: NCT02673996
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Satish Raj, University of Calgary

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.

Condition or disease Intervention/treatment
Postural Tachycardia Syndrome Drug: Phenylephrine Drug: Isoproterenol

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Pathophysiological Role of Adrenergic Antibodies in Postural Tachycardia Syndrome (Aims #1&2)
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : December 2022


Group/Cohort Intervention/treatment
Postural Tachycardia Syndrome (POTS)
Patients with postural tachycardia syndrome; patients will receive both IV phenylephrine and IV isoproterenol
Drug: Phenylephrine
incremental small doses of IV phenylephrine to find the dose that transiently raises systolic blood pressure by 25 mmHg
Other Name: NeoSynephrine

Drug: Isoproterenol
incremental small doses of IV isoproterenol to find the dose that transiently raises heart rate by 25 bpm
Other Name: Isuprel

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

Drug: Isoproterenol
incremental small doses of IV isoproterenol to find the dose that transiently raises heart rate by 25 bpm
Other Name: Isuprel




Primary Outcome Measures :
  1. The proportion of alpha-1 Ab titer positive subjects [ Time Frame: 1 Year (to measure Adrenergic antibody assay) ]
    The primary comparison will be the proportion of Ab titers between POTS patients compared to control subjects.


Secondary Outcome Measures :
  1. Antibody Positivity by Joint Hypermobility Status [ Time Frame: 1 Year (to measure Adrenergic antibody assay) ]
    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).

  2. Antibody Positivity by Clinical Autoimmune Syndromes [ Time Frame: 1 Year (to measure Adrenergic antibody assay) ]
    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.

  3. Antibody Positivity by Viral Onset of POTS [ Time Frame: 1 Year (to measure Adrenergic Antibody assay) ]
    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.

  4. Isoproterenol HR Increase (PD25) [ Time Frame: 1 Year (to measure Adrenergic Antibody assay) ]
    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.

  5. Phenylephrine Systolic BP Increase (PD25) [ Time Frame: 1 Year (to measure Adrenergic Antibody assay) ]
    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.

  6. The proportion of beta adrenergic Ab titer positive subjects [ Time Frame: 1 Year (to measure Adrenergic Antibody assay) ]
    The primary comparison will be the proportion of Ab titers between POTS patients


Biospecimen Retention:   Samples Without DNA
Serum for antibody assay; plasma for cytokine assessment; plasma for catecholamines


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with POstural Tachycardia Syndrome (POTS)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673996


Contacts
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Contact: Satish R Raj, MD, MSCI 403-210-6152 autonomic.research@ucalgary.ca
Contact: Robert S Sheldon, MD, PhD 403-220-8191 autonomic.research@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Satish R Raj, MD, MSCI    403-210-6152    autonomic.research@ucalgary.ca   
Contact: Robert S Sheldon, MD, PhD    403-220-8191    autonomic.research@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Satish R Raj, MD, MSCI University of Calgary

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Responsible Party: Dr. Satish Raj, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02673996     History of Changes
Other Study ID Numbers: REB15-2434
MOP142426 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Satish Raj, University of Calgary:
antibody
autoimmune
adrenergic
autonomic

Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Syndrome
Tachycardia
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Phenylephrine
Isoproterenol
Oxymetazoline
Adrenergic Agents
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Neurotransmitter Agents