- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05695755
Postural Tachycardia Syndrome and Vasovagal Syncope in Relation to Serum Electrolytes and Adrenal Insufficiency
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hossam M Abdelraheem
- Phone Number: 01064962263
- Email: solimanhosam943@gmai.com
Study Contact Backup
- Name: Hala Kh Elshreef
- Phone Number: 01120110000
- Email: halaelsherief@yahoo.com
Study Locations
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Assiut, Egypt, 71515
- Recruiting
- Assiut university
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Contact:
- Assiut University
- Phone Number: +2088241-1906
- Email: irbasyut@aun.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age Below 18 Yrs old
- patient with specific cardiac diseases
- Patient with Neurologic disorders
- patients on drugs that affect vasomotor tone of blood vessels
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
11/2022 to 10/2023
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Endocrine System Diseases
- Disease
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Autonomic Nervous System Diseases
- Unconsciousness
- Consciousness Disorders
- Primary Dysautonomias
- Orthostatic Intolerance
- Adrenal Gland Diseases
- Syndrome
- Tachycardia
- Syncope
- Postural Orthostatic Tachycardia Syndrome
- Syncope, Vasovagal
- Adrenal Insufficiency
Other Study ID Numbers
- PoTS and adrenal insufficiency
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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