Follow up of Moderate Aortic Regurge After Rheumatic Mitral Valve ReplacementNCT05680610
Follow up of Moderate Aortic Regurge After Mitral Valve Replacement
An observational study of Follow up of Moderate Aortic Regurge After Rheumatic Mitral Valve Replacement, run by Assiut University at 1 site in Egypt.
Trial summary
Aim of the study is to follow of of moderate aortic regurge after mitral valve replacement to figure out if the aortic regurge has been improved or it is getting worse Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Follow up of Moderate Aortic Regurge After Rheumatic Mitral Valve Replacement
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Oct 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients who underwent mitral valve replacement with untrated concomitant moderate aortic regurge in Asyut university hospitals
Who may be able to join
- patients underwent mitral valve replacement for rheumatic heart disease and having moderate aortic valve regurge GRADE 2 in assuit university hospitals
Who cannot join
- non rhumatic heart disease ,severe aortic regurge ,moderately severe aortic regurge ,combined ischmic and valvular heart diseaese
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine
Asyut, Assuit, 71125
Ahmed Wahba, 01090275757, Ahmedwahba663@gmail.com
About this study
Official title: Follow up of Moderate Aortic Regurge After Rhumatic Mitral Valve Replacement
Aim of the study is to follow of of moderate aortic regurge after mitral valve replacement to figure out if the aortic regurge has been improved or it is getting worse
Read the detailed description
A considerable proportion of patients who require mitral valve replacement present with a coexisting pathology of the aortic valve (AV). Rheumatic fever remains the leading cause for combined disease (1) Early series found that one-third of rheumatic hearts exhibited involvement of both mitral and aortic valve. The rate increased to 99% when the follow-up period was extended to 20 years The treatment of choice in cases in which one of the valves is moderately affected is questionable. Because combined aortic and mitral valve replacement is usually associated with higher risk and poorer long-term survival than replacement of either of the two valves alone (2) In patients with moderate aortic regurgitation who undergo mitral valve surgery). according to 2021 ESC/EACTS Guidelines, the decision to treat the aortic valve is controversial, as data show that progression of moderate aortic regurgitation is very slow in patients without aortic dilation (3) in contrast , In 2020 AHA guidelines recommended concomitant aortic valve replacement for moderate aortic regurgitation in patients undergoing surgery for ascending aorta, coronary artery bypass grafting (CABG),or mitral valve surgery (4-10) Because of this is a point of conflict we aim in this study to evaluate the saftey to leave moderate aortic regurge without intertvention as regarding operative time ,postoperative morbidity and mortality and progression of aortic valve regurge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between pre operative degree of aortic regurge and Postoperative degree of aortic regurge after rheumatic mitral valve replacement
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follow up of Moderate Aortic Regurge After Rheumatic Mitral Valve ReplacementStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed wahba, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680610
- Sponsor's protocol ID
- Assuit unimed
- Status last verified
- Jan 2023
- First submitted
- 31 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Moderate Aortic Regurge After Rhumatic Mitral Valve Replacement
- ClinicalTrials.gov ID
- NCT05680610
- Acronym / sponsor ID
- Assuit unimed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 11 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.
Aim of the study is to follow of of moderate aortic regurge after mitral valve replacement to figure out if the aortic regurge has been improved or it is getting worse
Detailed description
A considerable proportion of patients who require mitral valve replacement present with a coexisting pathology of the aortic valve (AV). Rheumatic fever remains the leading cause for combined disease (1) Early series found that one-third of rheumatic hearts exhibited involvement of both mitral and aortic valve. The rate increased to 99% when the follow-up period was extended to 20 years The treatment of choice in cases in which one of the valves is moderately affected is questionable. Because combined aortic and mitral valve replacement is usually associated with higher risk and poorer long-term survival than replacement of either of the two valves alone (2) In patients with moderate aortic regurgitation who undergo mitral valve surgery). according to 2021 ESC/EACTS Guidelines, the decision to treat the aortic valve is controversial, as data show that progression of moderate aortic regurgitation is very slow in patients without aortic dilation (3) in contrast , In 2020 AHA guidelines recommended concomitant aortic valve replacement for moderate aortic regurgitation in patients undergoing surgery for ascending aorta, coronary artery bypass grafting (CABG),or mitral valve surgery (4-10) Because of this is a point of conflict we aim in this study to evaluate the saftey to leave moderate aortic regurge without intertvention as regarding operative time ,postoperative morbidity and mortality and progression of aortic valve regurge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent mitral valve replacement with untrated concomitant moderate aortic regurge in Asyut university hospitals
Key inclusion criteria (1 listed)
- patients underwent mitral valve replacement for rheumatic heart disease and having moderate aortic valve regurge GRADE 2 in assuit university hospitals
Key exclusion criteria (1 listed)
- non rhumatic heart disease ,severe aortic regurge ,moderately severe aortic regurge ,combined ischmic and valvular heart diseaese
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
Comparison between pre operative degree of aortic regurge and Postoperative degree of aortic regurge after rheumatic mitral valve replacement
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
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 Follow up of Moderate Aortic Regurge After Rheumatic Mitral Valve Replacement, 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 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 11 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 Ahmed Wahba (01090275757, Ahmedwahba663@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between pre operative degree of aortic regurge and Postoperative degree of aortic regurge after rheumatic mitral valve replacement (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2023.