Cardiac ArrhythmiaNCT06490432
Pattern of Cardiac Arrhythmia in Patients With MASLD
An observational study of Cardiac Arrhythmia and Metabolic Dysfunction Associated Steatotic Liver Disease, run by Sohag University at 1 site in Egypt.
Trial summary
Study the relationship between patients with MASLD and cardiac arrhythmia that could be occur in thos patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrhythmia, Metabolic Dysfunction Associated Steatotic Liver Disease
- What is being tested?
- Transient elastography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jul 2024to 20 Oct 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study relationship between patients with metabolic dysfunction -assocatied steatotic liver disease and cardiac arrhythmia in those patients
Who may be able to join
- patients aged 18years or older Patients with metabolic dysfunction -assocatied steatotic liver disease
Who cannot join
- RHD Structural heart diseases Liver diseases other than MASLD
Trial locations and contacts
1 site in 1 country.
Usama Mohamed Abdalaal, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag, So
Magdy M Amin, Professor
About this study
Official title: Pattern of Cardiac Arrhythmia in Patients With Metabolic Dysfunction -Assocatied Steatotic Liver Disease in Sohag University Hospital.
Study the relationship between patients with MASLD and cardiac arrhythmia that could be occur in thos patients
Read the detailed description
Study the cardiac arrhythmia that could be occur in patients suffering form metabolic dysfunction -assocatied steatotic liver disease and risk factors of them
- Being tested
- Transient elastography
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient elastographyDevice
Also called Echocardiograpy, ECG
Device that measures stiffness of liver tissue
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac arrhythmia and MASLD patients
Study metabolic dysfunction -assocatied steatotic liver disease
Measured: 1 year
Cardiac arrhythmia
Study pattern of cardiac arrhythmia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start26 Jul 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion20 Oct 2025 (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 Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Rashwan Ahmed, Sohag University
- Investigators
- Mohamed Ahmed Mostafa, Lecturer, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490432
- Sponsor's protocol ID
- Soh-Med-24-06-04MS
- Status last verified
- Aug 2024
- First submitted
- 30 Jun 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee HH, Lee HA, Kim EJ, Kim HY, Kim HC, Ahn SH, Lee H, Kim SU. Metabolic dysfunction-associated steatotic liver disease and risk of cardiovascular disease. Gut. 2024 Feb 23;73(3):533-540. doi: 10.1136/gutjnl-2023-331003.
PubMed 37907259
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Cardiac Arrhythmia in Patients With Metabolic Dysfunction -Assocatied Steatotic Liver Disease in Sohag University Hospital.
- ClinicalTrials.gov ID
- NCT06490432
- Acronym / sponsor ID
- Soh-Med-24-06-04MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 8 Jul 2024 (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.
Study the relationship between patients with MASLD and cardiac arrhythmia that could be occur in thos patients
Detailed description
Study the cardiac arrhythmia that could be occur in patients suffering form metabolic dysfunction -assocatied steatotic liver disease and risk factors of them
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study relationship between patients with metabolic dysfunction -assocatied steatotic liver disease and cardiac arrhythmia in those patients
Key inclusion criteria (1 listed)
- patients aged 18years or older Patients with metabolic dysfunction -assocatied steatotic liver disease
Key exclusion criteria (1 listed)
- RHD Structural heart diseases Liver diseases other than MASLD
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 |
|---|---|---|
| Transient elastographyAlso: Echocardiograpy, ECGDevice that measures stiffness of liver tissue | Device | – |
Primary outcome
Cardiac arrhythmia and MASLD patients
Time frame: 1 year
Study metabolic dysfunction -assocatied steatotic liver disease
Cardiac arrhythmia
Time frame: 1 year
Study pattern of cardiac arrhythmia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 37907259Lee HH, Lee HA, Kim EJ, Kim HY, Kim HC, Ahn SH, Lee H, Kim SU. Metabolic dysfunction-associated steatotic liver disease and risk of cardiovascular disease. Gut. 2024 Feb 23;73(3):533-540. doi: 10.1136/gutjnl-2023-331003.
- Individual participant dataSharing planned: Undecided
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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.
Usama Mohamed Abdalaal, Professor contact
Mohamed Ahmed Mostafa, Lecturer study director
Sohag University
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 Cardiac Arrhythmia and Metabolic Dysfunction Associated Steatotic Liver Disease, run by Sohag 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 1 inclusion and 1 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 7 Aug 2024. 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 Asmaa Rashwan Ahmed, doctor (01118523043, asmarshwan5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac arrhythmia and MASLD patients (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06490432, 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 7 Aug 2024.