POTS Adrenergic Ab (CIHR Aims #1&2)
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| ClinicalTrials.gov Identifier: NCT02673996 |
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Recruitment Status :
Recruiting
First Posted : February 4, 2016
Last Update Posted : February 8, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Postural Tachycardia Syndrome | Drug: Phenylephrine Drug: Isoproterenol |
Show detailed description
| 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 2024 |
| Estimated Study Completion Date : | December 2025 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Postural Tachycardia Syndrome (POTS)
Patients with postural tachycardia syndrome; patients will receive both IV phenylephrine and IV isoproterenol
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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 |
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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
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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 |
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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
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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 |
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
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
| 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 |
| 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 | |
| Principal Investigator: | Satish R Raj, MD, MSCI | University of Calgary |
| Responsible Party: | Dr. Satish Raj, Professor, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT02673996 |
| 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: | February 8, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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antibody autoimmune adrenergic autonomic |
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Postural Orthostatic Tachycardia Syndrome Tachycardia Syndrome 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 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 Adrenergic Agents Neurotransmitter Agents |

