CClinicalTrials.gg
Status unknownNCT05695755Updated Jan 25, 2023

Postural Tachycardia Syndrome and Vasovagal Syncope in Relation to Serum Electrolytes and Adrenal Insufficiency

An observational study in POTS - Postural Orthostatic Tachycardia Syndrome, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-25.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

03

In context

Syncope

226 studies on the registry are indexed under Syncope; 45 are open to participants now.

This study's planned enrollment of 50 is below the median of 221 across 91 observational studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with inclusion criteria attending Internal Medicine Department, The Main Assiut University Hospital

Inclusion criteria

  1. Patient Above 18 years.
  2. 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.
  3. Patient with History of vasovagal syncope

Exclusion criteria

Exclusion Criteria:

  1. Age Below 18 Yrs old
  2. patient with specific cardiac diseases
  3. Patient with Neurologic disorders
  4. patients on drugs that affect vasomotor tone of blood vessels
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testECHO, Serum electrolytes

    echocardiography, serum electrolytes and cortisol level for all patients

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 11/2022 to 10/2023

07

Study locations

1 of 1 sites recruiting
  • Assiut University
    Assiut, 71515, Egypt
    Recruiting
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05695755
Lead sponsor
Assiut University
Responsible party
Hossam Mostafa Abdelraheem (Doctor, Assiut University) — Principal investigator
First posted
Jan 25, 2023
Start date
Nov 1, 2022
Primary completion
Sep 1, 2023 (estimated)
Completion
Oct 2023 (estimated)
Last update
Jan 25, 2023

Study contacts

Hossam M Abdelraheem
Contact
solimanhosam943@gmai.com
01064962263
Hala Kh Elshreef
Contact
halaelsherief@yahoo.com
01120110000

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion