Aortic RegurgitationNCT05774808
Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation
An observational study of Aortic Regurgitation and Functional Mitral Regurgitation, run by Michele De Bonis at 1 site in Italy.
Trial summary
Patients with severe aortic regurgitation (AR) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (MR). Tethering of the mitral valve leaflets and/or annular dilatation, both consequences of left ventricular dilatation, represent the most common mechanisms underlying the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Regurgitation, Functional Mitral Regurgitation
- What is being tested?
- Aortic valve replacement and Mitral valve annuloplasty
- Type of treatment
- Surgery or procedure
- How many people
- 154 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2022to 23 Feb 2022
- 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: Patients affected by severe AR and moderate MR. The patients are divided in 2 groups: in the Study group, patients underwent isolated aortic valve surgery, while in the Control group, mitral valve surgery was also added.
Who may be able to join
- Adult patients;
- Patients with severe aortic regurgitation (AR) AND moderate mitral regurgitation (MR).
- Patients underwent isolated aortic valve surgery (Study Group) or concomitant mitral valve surgery (Control Group) and
- Patients operated at the Cardiac Surgery Department of the San Raffaele Hospital from January 2004 to January 2019
Who cannot join
- Patient with more than moderate MR
Trial locations and contacts
1 site in 1 country.
About this study
Patients with severe aortic regurgitation (AR) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (MR). Tethering of the mitral valve leaflets and/or annular dilatation, both consequences of left ventricular dilatation, represent the most common mechanisms underlying the development of MR which can therefore be defined as "secondary" in this case.
When both mitral and aortic regurgitation are severe, patients show a decreased survival due to the pathophysiological consequences of the combination of these pathological conditions. In this case, surgery on both diseased valves is required to interrupt the natural history of the disease and is widely supported by current guidelines. On the other hand, little is known about the fate and prognostic implications of moderate MR secondary to severe AR and whether or not it should be treated at the time of aortic valve surgery. For this condition, the current guidelines do not provide specific recommendations, referring generically to the decision of the Heart Team.
Read more
To date, there are few data describing the evolution of moderate MR in patients undergoing surgery for severe AR and insufficient data to support recommendations regarding the treatment of moderate MR concurrently with treatment of AR, so that this decision is now entrusted to the evaluation of the Heart Team. It is therefore desirable to evaluate the outcomes of these patients.
The aim of this study is to evaluate the short- and long-term fate of secondary moderate MR in patients undergoing aortic valve replacement for severe AR.
- Being tested
- Aortic valve replacement, Mitral valve annuloplasty
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve replacementProcedure or surgery
An aortic valve prosthesis is surgically implanted to treat AR
Mitral valve annuloplastyProcedure or surgery
Surgical repair of the mitral valve in which a prosthetic ring is implanted to treat MR
| Study group | Role | What they receive |
|---|---|---|
| Aortic valve surgery only | Not described Receives: Procedure: Aortic valve replacement | |
| Aortic valve + mitral valve surgery | Not described Receives: Procedure: Aortic valve replacement; Procedure: Mitral valve annuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality for cardiac causes
Measured: Through study completion, an average of 7 years
Secondary outcomes (4)
All causes mortality
Measured: Through study completion, an average of 7 years
Severe AR recurrency
Measured: Through study completion, an average of 7 years
Reintervention for severe AR recurrency
Measured: Through study completion, an average of 7 years
Reintervention for severe MR
Measured: Through study completion, an average of 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start2 Feb 2022
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michele De Bonis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michele De Bonis, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774808
- Sponsor's protocol ID
- MOSMIR-SAR
- Status last verified
- Mar 2023
- First submitted
- 30 Jan 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- 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 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation
- ClinicalTrials.gov ID
- NCT05774808
- Acronym / sponsor ID
- MOSMIR-SAR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Michele De BonisUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 20 Mar 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.
Patients with severe aortic regurgitation (AR) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (MR). Tethering of the mitral valve leaflets and/or annular dilatation, both consequences of left ventricular dilatation, represent the most common mechanisms underlying the development of MR which can therefore be defined as "secondary" in this case.
When both mitral and aortic regurgitation are severe, patients show a decreased survival due to the pathophysiological consequences of the combination of these pathological conditions. In this case, surgery on both diseased valves is required to interrupt the natural history of the disease and is widely supported by current guidelines. On the other hand, little is known about the fate and prognostic implications of moderate MR secondary to severe AR and whether or not it should be treated at the time of aortic valve surgery. For this condition, the current guidelines do not provide specific recommendations, referring generically to the decision of the Heart Team.
To date, there are few data describing the evolution of moderate MR in patients undergoing surgery for severe AR and insufficient data to support recommendations regarding the treatment of moderate MR concurrently with treatment of AR, so that this decision is now entrusted to the evaluation of the Heart Team. It is therefore desirable to evaluate the outcomes of these patients.
The aim of this study is to evaluate the short- and long-term fate of secondary moderate MR in patients undergoing aortic valve replacement for severe AR.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aortic valve surgery only | – | Procedure: Aortic valve replacement |
| Aortic valve + mitral valve surgery | – | Procedure: Aortic valve replacement, Procedure: Mitral valve annuloplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by severe AR and moderate MR. The patients are divided in 2 groups: in the Study group, patients underwent isolated aortic valve surgery, while in the Control group, mitral valve surgery was also added.
Key inclusion criteria (4 listed)
- Adult patients;
- Patients with severe aortic regurgitation (AR) AND moderate mitral regurgitation (MR).
- Patients underwent isolated aortic valve surgery (Study Group) or concomitant mitral valve surgery (Control Group) and
- Patients operated at the Cardiac Surgery Department of the San Raffaele Hospital from January 2004 to January 2019
Key exclusion criteria (1 listed)
- Patient with more than moderate MR
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 |
|---|---|---|
| Aortic valve replacementAn aortic valve prosthesis is surgically implanted to treat AR | Procedure or surgery | Aortic valve + mitral valve surgery, Aortic valve surgery only |
| Mitral valve annuloplastySurgical repair of the mitral valve in which a prosthetic ring is implanted to treat MR | Procedure or surgery | Aortic valve + mitral valve surgery |
Primary outcome
Mortality for cardiac causes
Time frame: Through study completion, an average of 7 years
4 secondary outcomes
All causes mortality
Time frame: Through study completion, an average of 7 years
Severe AR recurrency
Time frame: Through study completion, an average of 7 years
Reintervention for severe AR recurrency
Time frame: Through study completion, an average of 7 years
Reintervention for severe MR
Time frame: Through study completion, an average of 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aortic Regurgitation and Functional Mitral Regurgitation, run by Michele De Bonis at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 20 Mar 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality for cardiac causes (time frame: Through study completion, an average of 7 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 20 Mar 2023.