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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 May 2023 |
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Main ID: |
NCT02673996 |
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Date of registration:
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28/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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POTS Adrenergic Ab (CIHR Aims #1&2)
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Scientific title:
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The Pathophysiological Role of Adrenergic Antibodies in Postural Tachycardia Syndrome (Aims #1&2) |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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125 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02673996 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Satish R Raj, MD, MSCI |
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Address:
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Telephone:
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403-210-6152 |
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Email:
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autonomic.research@ucalgary.ca |
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Affiliation:
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Name:
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Satish R Raj, MD, MSCI |
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Address:
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Telephone:
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403-210-6152 |
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Email:
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autonomic.research@ucalgary.ca |
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Affiliation:
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Name:
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Satish R Raj, MD, MSCI |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Calgary |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Postural Tachycardia Syndrome
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Intervention(s)
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Drug: Phenylephrine
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Drug: Isoproterenol
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Primary Outcome(s)
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The proportion of alpha-1 Ab titer positive subjects
[Time Frame: 1 Year (to measure Adrenergic antibody assay)]
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Secondary Outcome(s)
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Antibody Positivity by Clinical Autoimmune Syndromes
[Time Frame: 1 Year (to measure Adrenergic antibody assay)]
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The proportion of beta adrenergic Ab titer positive subjects
[Time Frame: 1 Year (to measure Adrenergic Antibody assay)]
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Isoproterenol HR Increase (PD25)
[Time Frame: 1 Year (to measure Adrenergic Antibody assay)]
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Phenylephrine Systolic BP Increase (PD25)
[Time Frame: 1 Year (to measure Adrenergic Antibody assay)]
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Antibody Positivity by Viral Onset of POTS
[Time Frame: 1 Year (to measure Adrenergic Antibody assay)]
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Antibody Positivity by Joint Hypermobility Status
[Time Frame: 1 Year (to measure Adrenergic antibody assay)]
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Secondary ID(s)
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REB15-2434
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MOP142426
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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