Functional Mitral RegurgitationNCT05566340
Treatment of Moderate FMR During AVR
An observational study of Functional Mitral Regurgitation, run by Fuwai Yunnan Cardiovascular Hospital.
Trial summary
Debates exist on the treatment of moderate functional mitral regurgitation (FMR) in patients undergoing aortic valve replacement (AVR) for aortic valve disease. This study aims to evaluate the left ventricular function, which was evaluated through global longitudinal strain, after isolated AVR and AVR + mitral valve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Mitral Regurgitation
- What is being tested?
- mitral valve repair
- Type of treatment
- Surgery or procedure
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 2023
- How long will I take part?
- 6 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: A total of 154 patients with moderate FMR undergoing isolated AVR or AVR + MVr will be prospectively enrolled.
Who may be able to join
- Patients who received AVR (with or without concomitant MVr) from two center (Fuwai Yunnan Cardiovascular Hospital and Fuwai Hospital, Chinese Academy of Medical Sciences).
- Age more than 18 years.
Who cannot join
- Those with a history of rheumatic valvular disease or infective endocarditis.
- Primary mitral valve lesions.
- Patients receiving mitral valve replacement.
- Patient who refuse to participate in this study, or cannot complete 6-month follow-up after surgery.
- Age < 18 years.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Surgical Treatment of Aortic Valve Disease With Moderate Functional Mitral Regurgitation
Debates exist on the treatment of moderate functional mitral regurgitation (FMR) in patients undergoing aortic valve replacement (AVR) for aortic valve disease. This study aims to evaluate the left ventricular function, which was evaluated through global longitudinal strain, after isolated AVR and AVR + mitral valve repair (MVr) in this group of patients.
- Conditions
- Functional Mitral Regurgitation
- Being tested
- mitral valve repair
- Keywords
- functional mitral regurgitation, aortic valve replacement, mitral valve repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve repairProcedure or surgery
Repair of mitral valve concomitant to aortic valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| isolated aortic valve replacement group | Isolated aortic valve replacement surgery. Receives: Procedure: mitral valve repair | |
| aortic valve replacement with mitral valve repair group | Aortic valve replacement with mitral valve repair Receives: Procedure: mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular global longitudinal strain
The change of left ventricular global longitudinal strain compared to before surgery
Measured: 10/10/2022-10/10/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Mitral RegurgitationStudies of the same condition, open and under way.
- 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
- 154 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fuwai Yunnan Cardiovascular Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566340
- Sponsor's protocol ID
- FZX2019-06-01 2022YFKY088
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- 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 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Aortic Valve Disease With Moderate Functional Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT05566340
- Acronym / sponsor ID
- FZX2019-06-01 2022YFKY088
- Conditions
- Functional Mitral Regurgitation
- Keywords
- functional mitral regurgitation, aortic valve replacement, mitral valve repair
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Fuwai Yunnan Cardiovascular HospitalUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Oct 2022 (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.
Debates exist on the treatment of moderate functional mitral regurgitation (FMR) in patients undergoing aortic valve replacement (AVR) for aortic valve disease. This study aims to evaluate the left ventricular function, which was evaluated through global longitudinal strain, after isolated AVR and AVR + mitral valve repair (MVr) in this group of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isolated aortic valve replacement group | – | Procedure: mitral valve repairIsolated aortic valve replacement surgery. |
| aortic valve replacement with mitral valve repair group | – | Procedure: mitral valve repairAortic valve replacement with mitral valve repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 154 patients with moderate FMR undergoing isolated AVR or AVR + MVr will be prospectively enrolled.
Key inclusion criteria (2 listed)
- Patients who received AVR (with or without concomitant MVr) from two center (Fuwai Yunnan Cardiovascular Hospital and Fuwai Hospital, Chinese Academy of Medical Sciences).
- Age more than 18 years.
Key exclusion criteria (5 listed)
- Those with a history of rheumatic valvular disease or infective endocarditis.
- Primary mitral valve lesions.
- Patients receiving mitral valve replacement.
- Patient who refuse to participate in this study, or cannot complete 6-month follow-up after surgery.
- Age < 18 years.
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 |
|---|---|---|
| mitral valve repairRepair of mitral valve concomitant to aortic valve replacement. | Procedure or surgery | aortic valve replacement with mitral valve repair group, isolated aortic valve replacement group |
Primary outcome
left ventricular global longitudinal strain
Time frame: 10/10/2022-10/10/2023
The change of left ventricular global longitudinal strain compared to before surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Mitral Regurgitation, run by Fuwai Yunnan Cardiovascular Hospital.
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 2 inclusion and 5 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 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Xieraili Tiemuerniyazi (+86-18814115887, tiemuernyz@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular global longitudinal strain (time frame: 10/10/2022-10/10/2023). 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 4 Oct 2022.