POTS - Postural Orthostatic Tachycardia SyndromeNCT05695755
Postural Tachycardia Syndrome and Vasovagal Syncope in Relation to Serum Electrolytes and Adrenal Insufficiency
An observational study of POTS - Postural Orthostatic Tachycardia Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
The present study aims to: 1. Estimate the prevalence of Postural Tachycardia Syndrome and vasovagal syncope among adults patients attend the Internal Medicine Clinic and ICU in period from 11/2022 to 10/2023 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- POTS - Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- ECHO, Serum electrolytes
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with inclusion criteria attending Internal Medicine Department, The Main Assiut University Hospital
Who may be able to join
- Patient Above 18 years.
- Patient fulfilling diagnostic criteria of POTS increase heart rate from supine position to active standing by > 30 beat per minute within 10 minutes and positive poor mans man tilt table test.
- Patient with History of vasovagal syncope
Who cannot join
- Age Below 18 Yrs old
- patient with specific cardiac diseases
- Patient with Neurologic disorders
- patients on drugs that affect vasomotor tone of blood vessels
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Assiut University, +2088241-1906, irbasyut@aun.edu.eg
About this study
Official title: Postural Tachycardia Syndrome and Vasovagal Syncope in Relation to Serum Electrolytes and Adrenal Insufficiency Among Adults Attending the Main Assiut University Hospital
The present study aims to:
- Estimate the prevalence of Postural Tachycardia Syndrome and vasovagal syncope among adults patients attend the Internal Medicine Clinic and ICU in period from 11/2022 to 10/2023
- Detect of causes and the relationship between POTS and vasovagal syncope and serum electrolytes, and serum cortisol.
Read the detailed description
Postural Orthostatic Tachycardia Syndrome (POTS) is a common, although not so well-known variant of cardiovascular autonomic disorder characterized by an excessive heart rate increase on standing, symptoms of orthostatic intolerance and maybe syncope.
The most common complaints are dizziness, weakness, rapid heartbeat and palpitation on standing. Moreover, patients often report physical deconditioning and reduced exercise capacity as well as headache, brain fog, dyspnea, gastrointestinal disorders and musculoskeletal pain.
The etiology of POTS is largely unknown and three main hypotheses include an autoimmune disorder, abnormally increased sympathetic activity and catecholamine excess and sympathetic denervation leading to central hypervolemia and reflex tachycardia. The diagnostic criteria of POTS in this study is increasing hear rate from supine position to active standing by > 30 beat per minute and positive poor mans man tilt table test.
On the other hand, Vasovagal Reflex Syncope is the most frequent cause of transient loss of consciousness . The vasovagal reaction consists of vasodilatation and a heart rate decrease. During prolonged standing, this reaction is triggered by a reduction of the central blood volume because of pooling in the lower body veins, sometimes combined with other provocative factors . Patients with reflex syncope may suffer from recurrent loss of consciousness. Most of those patients also experience frequent presyncope, which can be just as incapacitating as syncope itself. Vasovagal syncope is usually not a dangerous condition, because episodes are self-limiting. However, the quality of life of patients with recurrences can be seriously affected . The rapid loss of consciousness and the possibility of trauma tax the patients sense of physical control and self-esteem.
- Being tested
- ECHO, Serum electrolytes
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHO, Serum electrolytesDiagnostic test
echocardiography, serum electrolytes and cortisol level for all patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the prevalence of Postural Tachycardia Syndrome and vasovagal syncope
Estimate the prevalence of Postural Tachycardia Syndrome and vasovagal syncope among adults patients attend the Internal Medicine Clinic and IC Detect of causes and the relationship between POTS and vasovagal syncope and serum electrolytes, and serum cortisol.
Measured: 11/2022 to 10/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Nov 2022
- Primary completion1 Sep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for POTS - Postural Orthostatic Tachycardia SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Mostafa Abdelraheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695755
- Sponsor's protocol ID
- PoTS and adrenal insufficiency
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, Cheshire WP, Chelimsky T, Cortelli P, Gibbons CH, Goldstein DS, Hainsworth R, Hilz MJ, Jacob G, Kaufmann H, Jordan J, Lipsitz LA, Levine BD, Low PA, Mathias C, Raj SR, Robertson D, Sandroni P, Schatz IJ, Schondorf R, Stewart JM, van Dijk JG. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Auton Neurosci. 2011 Apr 26;161(1-2):46-8. doi: 10.1016/j.autneu.2011.02.004. Epub 2011 Mar 9. No abstract available.
PubMed 21393070
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Tachycardia Syndrome and Vasovagal Syncope in Relation to Serum Electrolytes and Adrenal Insufficiency Among Adults Attending the Main Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05695755
- Acronym / sponsor ID
- PoTS and adrenal insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to:
- Estimate the prevalence of Postural Tachycardia Syndrome and vasovagal syncope among adults patients attend the Internal Medicine Clinic and ICU in period from 11/2022 to 10/2023
- Detect of causes and the relationship between POTS and vasovagal syncope and serum electrolytes, and serum cortisol.
Detailed description
Postural Orthostatic Tachycardia Syndrome (POTS) is a common, although not so well-known variant of cardiovascular autonomic disorder characterized by an excessive heart rate increase on standing, symptoms of orthostatic intolerance and maybe syncope.
The most common complaints are dizziness, weakness, rapid heartbeat and palpitation on standing. Moreover, patients often report physical deconditioning and reduced exercise capacity as well as headache, brain fog, dyspnea, gastrointestinal disorders and musculoskeletal pain.
The etiology of POTS is largely unknown and three main hypotheses include an autoimmune disorder, abnormally increased sympathetic activity and catecholamine excess and sympathetic denervation leading to central hypervolemia and reflex tachycardia. The diagnostic criteria of POTS in this study is increasing hear rate from supine position to active standing by > 30 beat per minute and positive poor mans man tilt table test.
On the other hand, Vasovagal Reflex Syncope is the most frequent cause of transient loss of consciousness . The vasovagal reaction consists of vasodilatation and a heart rate decrease. During prolonged standing, this reaction is triggered by a reduction of the central blood volume because of pooling in the lower body veins, sometimes combined with other provocative factors . Patients with reflex syncope may suffer from recurrent loss of consciousness. Most of those patients also experience frequent presyncope, which can be just as incapacitating as syncope itself. Vasovagal syncope is usually not a dangerous condition, because episodes are self-limiting. However, the quality of life of patients with recurrences can be seriously affected . The rapid loss of consciousness and the possibility of trauma tax the patients sense of physical control and self-esteem.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with inclusion criteria attending Internal Medicine Department, The Main Assiut University Hospital
Key inclusion criteria (3 listed)
- Patient Above 18 years.
- Patient fulfilling diagnostic criteria of POTS increase heart rate from supine position to active standing by > 30 beat per minute within 10 minutes and positive poor mans man tilt table test.
- Patient with History of vasovagal syncope
Key exclusion criteria (4 listed)
- Age Below 18 Yrs old
- patient with specific cardiac diseases
- Patient with Neurologic disorders
- patients on drugs that affect vasomotor tone of blood vessels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECHO, Serum electrolytesechocardiography, serum electrolytes and cortisol level for all patients | Diagnostic test | – |
Primary outcome
Estimate the prevalence of Postural Tachycardia Syndrome and vasovagal syncope
Time frame: 11/2022 to 10/2023
Estimate the prevalence of Postural Tachycardia Syndrome and vasovagal syncope among adults patients attend the Internal Medicine Clinic and IC Detect of causes and the relationship between POTS and vasovagal syncope and serum electrolytes, and serum cortisol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 21393070Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, Cheshire WP, Chelimsky T, Cortelli P, Gibbons CH, Goldstein DS, Hainsworth R, Hilz MJ, Jacob G, Kaufmann H, Jordan J, Lipsitz LA, Levine BD, Low PA, Mathias C, Raj SR, Robertson D, Sandroni P, Schatz IJ, Schondorf R, Stewart JM, van Dijk JG. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Auton Neurosci. 2011 Apr 26;161(1-2):46-8. doi: 10.1016/j.autneu.2011.02.004. Epub 2011 Mar 9. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of POTS - Postural Orthostatic Tachycardia Syndrome, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hossam M Abdelraheem (01064962263, solimanhosam943@gmai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the prevalence of Postural Tachycardia Syndrome and vasovagal syncope (time frame: 11/2022 to 10/2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05695755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.