Mitral Valve ProlapseNCT06741709
A Study of Mitral Annular Disjunction in Mitral Valve Prolapse Patients and Arrhythmia Risk
An observational study of Mitral Valve Prolapse and Mitral Valve Insufficiency, run by Assiut University at 1 site in Egypt.
Trial summary
This study investigates the characteristics and prevalence of mitral annular disjunction in patients with mitral valve prolapse with severe mitral regurgitation (MR) at Assiut University Heart Hospital. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Mitral Valve Prolapse, Mitral Valve Insufficiency
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Feb 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 30
Who may be able to join
- All consecutive patients > 18 years of age presenting to Assiut University Heart Hospital with MVP and more than moderate MR.
Who cannot join
- Previous mitral valve surgery.
- MVP due to infective endocarditis.
- Moderate or more significant aortic stenosis, aortic regurgitation or mitral stenosis.
- Congenital heart disease and poor image quality precluding accurate assessment of the mitral valve.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University
Asyut, Asyut Governorate, 71111
Kerolos R. Girgis, MA, 01272872479, kerorezk37@gmail.com
About this study
This study investigates the characteristics and prevalence of mitral annular disjunction in patients with mitral valve prolapse with severe mitral regurgitation (MR) at Assiut University Heart Hospital.
Read the detailed description
Mitral annular disjunction is a structural defect of the mitral annulus fibrous commonly associated with mitral leaflet prolapse. However, there have been few cases of mitral annular disjunction in mitral valve prolapse (MVP).
Mitral annular disjunction (MAD) is a structural defect characterized by a clear separation between the mitral valve annulus, the left atrium wall, and the myocardial continuity. This condition can be seen in a 360-degree circle around the mitral valve annulus. However, it is most typically seen in the inferolateral myocardium, right behind the posterior mitral valve leaflet. It is generally present in the P1 and P2 mitral valve scallops.
Mitral valve prolapse (MVP) occurs in 3% of the population and is the most common reason for mitral valve replacement[1]. According to population and cohort studies, the patient's age significantly influences mitral valve prolapse (MVP) outcomes, left ventricular ejection fraction, and the severity of mitral regurgitation. Mitral regurgitation has little influence if it is not severe. While the link between MVP and sudden cardiac death was first discovered many years ago, it was once assumed to be extremely low risk. Recent observational studies have found a link between MVP and malignant ventricular arrhythmias, as well as sudden cardiac death, in a particular population of young and middle-aged people. This raise worries regarding the existence of an arrhythmic MVP variation. Recent research has led to a better knowledge of the aberrant physiological processes and circumstances that enhance the likelihood of developing irregular heart rhythms in people with mitral valve prolapse.
The diagnosis of mitral valve regurgitation can be accurately determined by non-invasive imaging techniques such as transthoracic echocardiography, Transesophageal echocardiography, and cardiac magnetic resonance imaging.
This study tries to improve patient risk assessment
- Conditions
- Mitral Valve Prolapse, Mitral Valve Insufficiency
- Keywords
- Mitral annular disjunction
- Medical subject headings
- Mitral Valve Prolapse, Mitral Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the prevalence of mitral annular disjunction in patients with mitral valve prolapse
Detect the prevalence of mitral annular disjunction in patients with mitral valve prolapse
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start14 Feb 2025 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve ProlapseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolos Rezk Ayad Girgis, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741709
- Sponsor's protocol ID
- Mitral annulus disjunction
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hussain N, Bhagia G, Doyle M, Rayarao G, Williams RB, Biederman RWW. Mitral annular disjunction; how accurate are we? A cardiovascular MRI study defining risk. Int J Cardiol Heart Vasc. 2023 Nov 9;49:101298. doi: 10.1016/j.ijcha.2023.101298. eCollection 2023 Dec.
PubMed 38035256Tison GH, Abreau S, Barrios J, Lim LJ, Yang M, Crudo V, Shah DJ, Nguyen T, Hu G, Dixit S, Nah G, Arya F, Bibby D, Lee Y, Delling FN. Identifying Mitral Valve Prolapse at Risk for Arrhythmias and Fibrosis From Electrocardiograms Using Deep Learning. JACC Adv. 2023 Aug;2(6):100446. doi: 10.1016/j.jacadv.2023.100446. Epub 2023 Aug 5.
PubMed 37936601Donal E, Galli E, Letourneau T. Need for expertise in mitral valve regurgitation. Open Heart. 2019 Apr 28;6(1):e001039. doi: 10.1136/openhrt-2019-001039. eCollection 2019. No abstract available.
PubMed 31168391Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.
PubMed 28314623
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Mitral Annular Disjunction in Mitral Valve Prolapse Patients and Arrhythmia Risk
- ClinicalTrials.gov ID
- NCT06741709
- Acronym / sponsor ID
- Mitral annulus disjunction
- Conditions
- Mitral Valve Prolapse, Mitral Valve Insufficiency
- Keywords
- Mitral annular disjunction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Feb 2025 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Dec 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.
This study investigates the characteristics and prevalence of mitral annular disjunction in patients with mitral valve prolapse with severe mitral regurgitation (MR) at Assiut University Heart Hospital.
Detailed description
Mitral annular disjunction is a structural defect of the mitral annulus fibrous commonly associated with mitral leaflet prolapse. However, there have been few cases of mitral annular disjunction in mitral valve prolapse (MVP).
Mitral annular disjunction (MAD) is a structural defect characterized by a clear separation between the mitral valve annulus, the left atrium wall, and the myocardial continuity. This condition can be seen in a 360-degree circle around the mitral valve annulus. However, it is most typically seen in the inferolateral myocardium, right behind the posterior mitral valve leaflet. It is generally present in the P1 and P2 mitral valve scallops.
Mitral valve prolapse (MVP) occurs in 3% of the population and is the most common reason for mitral valve replacement[1]. According to population and cohort studies, the patient's age significantly influences mitral valve prolapse (MVP) outcomes, left ventricular ejection fraction, and the severity of mitral regurgitation. Mitral regurgitation has little influence if it is not severe. While the link between MVP and sudden cardiac death was first discovered many years ago, it was once assumed to be extremely low risk. Recent observational studies have found a link between MVP and malignant ventricular arrhythmias, as well as sudden cardiac death, in a particular population of young and middle-aged people. This raise worries regarding the existence of an arrhythmic MVP variation. Recent research has led to a better knowledge of the aberrant physiological processes and circumstances that enhance the likelihood of developing irregular heart rhythms in people with mitral valve prolapse.
The diagnosis of mitral valve regurgitation can be accurately determined by non-invasive imaging techniques such as transthoracic echocardiography, Transesophageal echocardiography, and cardiac magnetic resonance imaging.
This study tries to improve patient risk assessment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 30
Key inclusion criteria (1 listed)
- All consecutive patients > 18 years of age presenting to Assiut University Heart Hospital with MVP and more than moderate MR.
Key exclusion criteria (4 listed)
- Previous mitral valve surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detect the prevalence of mitral annular disjunction in patients with mitral valve prolapse
Time frame: six months
Detect the prevalence of mitral annular disjunction in patients with mitral valve prolapse
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Background: PubMed 38035256Hussain N, Bhagia G, Doyle M, Rayarao G, Williams RB, Biederman RWW. Mitral annular disjunction; how accurate are we? A cardiovascular MRI study defining risk. Int J Cardiol Heart Vasc. 2023 Nov 9;49:101298. doi: 10.1016/j.ijcha.2023.101298. eCollection 2023 Dec.
- Background: PubMed 37936601Tison GH, Abreau S, Barrios J, Lim LJ, Yang M, Crudo V, Shah DJ, Nguyen T, Hu G, Dixit S, Nah G, Arya F, Bibby D, Lee Y, Delling FN. Identifying Mitral Valve Prolapse at Risk for Arrhythmias and Fibrosis From Electrocardiograms Using Deep Learning. JACC Adv. 2023 Aug;2(6):100446. doi: 10.1016/j.jacadv.2023.100446. Epub 2023 Aug 5.
- Background: PubMed 31168391Donal E, Galli E, Letourneau T. Need for expertise in mitral valve regurgitation. Open Heart. 2019 Apr 28;6(1):e001039. doi: 10.1136/openhrt-2019-001039. eCollection 2019. No abstract available.
- Background: PubMed 28314623Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.
- 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.
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 Mitral Valve Prolapse and Mitral Valve Insufficiency, 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 1 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: opening soon, as of the sponsor's last update on 19 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerolos R. Ayad, MA (+2 01272872479, kerorezk37@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the prevalence of mitral annular disjunction in patients with mitral valve prolapse (time frame: six months). 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 NCT06741709, which also lists 4 linked publications.
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 19 Dec 2024.