Aortic Valve RegurgitationORMIXNCT06805253
Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
An observational study of Aortic Valve Regurgitation and Mitral Valve Regurgitation, run by Petrovsky National Research Centre of Surgery at 2 sites in Russia.
Trial summary
Investigators assume that surgical correction approach to functional mitral regurgitation during intervention for chronic aortic regurgitation in patients with severe enlargement of the left heart chambers influences reverse remodeling of the left ventricle (LV) in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Regurgitation, Mitral Valve Regurgitation, Left Ventricle Dilated
- What is being tested?
- Not applicable - observational study
- How many people
- 120 participants
- Where
- 2 sitesRussia
- Study dates
- 9 May 2024to May 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent open surgical correction of aortic insufficiency with the background of severe eccentric remodeling of the left ventricle (EDV more than 250 ml). Men and women over 18 years of age.
Who may be able to join
- Age over 18 years
- Planned primary elective surgery for chronic aortic regurgitation
- Presence of functional mitral regurgitation
- End-diastolic volume of the left ventricle \>= 250 ml
Who cannot join
- Infectious endocarditis
- History of myocardial infarction
- Indications on simultaneous myocardial revascularisation
- Acute aortic regurgitation of any etiology
- Previously diagnosed dilatation of the left ventricle, not associated with the development of aortic regurgitation
- Long-term persistent or permanent form of atrial fibrillation
Show all 13Show fewer
- Pregnancy in the first 12 months after surgery
- Simultaneous participation in other studies
- Presence of implanted pacemakers
- Refusal to sign informed consent
- Acute coronary event diagnosed within 12 months after aortic valve surgery
- Indications for resynchronization therapy or permanent right ventricular pacing in the first 12 months after aortic valve surgery
- Re-do cardiac surgery for any reason within 12 months after aortic valve surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites, 2 recruiting
- Recruiting
Petrovsky National Research Center of Surgery
Moscow, 119435
Eduard Charchyan, professor, +79262174114, charchmed@yahoo.com
- Recruiting
Voronezh Regional Clinical Hospital No. 1
Voronezh, 394066
Andrei Bulynin, +79081339584, bandrew@inbox.ru
About this study
Official title: Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment
Investigators assume that surgical correction approach to functional mitral regurgitation during intervention for chronic aortic regurgitation in patients with severe enlargement of the left heart chambers influences reverse remodeling of the left ventricle (LV) in the postoperative period. It is suggested that functional mitral regurgitation (MR) provides supra-physiological left ventricle volume overload and this fact plays positive role in early-stage post-operative left ventricle volume and function recovery. LV volume, systolic and diastolic function will be monitored with echocardiography (EchoCG) along with life quality in patients with different grades of functional mitral regurgitation secondary to severe chronic aortic insufficiency after surgical treatment of aortic regurgitation.
- Conditions
- Aortic Valve Regurgitation, Mitral Valve Regurgitation, Left Ventricle Dilated, Left Atrium Dilated, Systolic Left Ventricular Heart Failure, Diastolic Heart Failure
- Being tested
- Not applicable - observational study
- Keywords
- reverse remodeling, left ventricle dilatation, mitral valve functional regurgitation recovery, left ventricle reverse remodeling
- Medical subject headings
- Aortic Valve Insufficiency, Mitral Valve Insufficiency, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable - observational studyOther
Also called observation
observation only
| Study group | Role | What they receive |
|---|---|---|
| MR < 2 no MvR | Patients with functional mitral regurgitation grade 0-1, 1 and 1-2 without mitral valve repair (MvR) Receives: Other: Not applicable - observational study | |
| MR >= 2 no MvR | Patients with mitral valve functional regurgitation of grade 2 and more severe without mitral valve repair Receives: Other: Not applicable - observational study | |
| MR < 2 MvR | Patients with functional mitral regurgitation grade 0-1, 1 and 1-2, mitral valve repaired Receives: Other: Not applicable - observational study | |
| MR >= 2 MvR | Patients with mitral valve functional regurgitation of grade 2 and more severe, mitral valve repaired Receives: Other: Not applicable - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV end-diastolic volume (EDV) decrease
Change in end-diastolic volume of the left ventricle, assessed with EchoCG after surgical correction of aortic insufficiency
Measured: 3 and 12 months after surgery
Freedom from readmission
Freedom from readmission due to valvular problem or heart failure-related reason
Measured: 12 months after surgery
Secondary outcomes (1)
Life quality
The patient's life quality according to the results of the EuroQol-5D-5L (EQ-5D-5L) questionnaire (0-100 points, the higher - the better).
Measured: Upon inclusion, 10 days post-surgery, 3 month and 12 month post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start9 May 2024
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Voronezh regional clinical hospital #1
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805253
- Sponsor's protocol ID
- 173538086
- Acronym
- ORMIX
- Status last verified
- Jun 2025
- First submitted
- 18 Oct 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment
- ClinicalTrials.gov ID
- NCT06805253
- Acronym / sponsor ID
- ORMIX / 173538086
- Conditions
- Aortic Valve Regurgitation, Mitral Valve Regurgitation, Left Ventricle Dilated, Left Atrium Dilated, Systolic Left Ventricular Heart Failure, Diastolic Heart Failure
- Keywords
- reverse remodeling, left ventricle dilatation, mitral valve functional regurgitation recovery, left ventricle reverse remodeling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Collaborators
- Voronezh regional clinical hospital #1
- Study start
- 9 May 2024 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 3 Feb 2025 (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.
Investigators assume that surgical correction approach to functional mitral regurgitation during intervention for chronic aortic regurgitation in patients with severe enlargement of the left heart chambers influences reverse remodeling of the left ventricle (LV) in the postoperative period. It is suggested that functional mitral regurgitation (MR) provides supra-physiological left ventricle volume overload and this fact plays positive role in early-stage post-operative left ventricle volume and function recovery. LV volume, systolic and diastolic function will be monitored with echocardiography (EchoCG) along with life quality in patients with different grades of functional mitral regurgitation secondary to severe chronic aortic insufficiency after surgical treatment of aortic regurgitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MR < 2 no MvR | – | Other: Not applicable - observational studyPatients with functional mitral regurgitation grade 0-1, 1 and 1-2 without mitral valve repair (MvR) |
| MR >= 2 no MvR | – | Other: Not applicable - observational studyPatients with mitral valve functional regurgitation of grade 2 and more severe without mitral valve repair |
| MR < 2 MvR | – | Other: Not applicable - observational studyPatients with functional mitral regurgitation grade 0-1, 1 and 1-2, mitral valve repaired |
| MR >= 2 MvR | – | Other: Not applicable - observational studyPatients with mitral valve functional regurgitation of grade 2 and more severe, mitral valve repaired |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent open surgical correction of aortic insufficiency with the background of severe eccentric remodeling of the left ventricle (EDV more than 250 ml). Men and women over 18 years of age.
Key inclusion criteria (4 listed)
- Age over 18 years
- Planned primary elective surgery for chronic aortic regurgitation
- Presence of functional mitral regurgitation
- End-diastolic volume of the left ventricle \>= 250 ml
Key exclusion criteria (13 listed)
- Infectious endocarditis
- History of myocardial infarction
- Indications on simultaneous myocardial revascularisation
- Acute aortic regurgitation of any etiology
- Previously diagnosed dilatation of the left ventricle, not associated with the development of aortic regurgitation
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 |
|---|---|---|
| Not applicable - observational studyAlso: observationobservation only | Other | MR < 2 MvR, MR < 2 no MvR, MR >= 2 MvR, MR >= 2 no MvR |
Primary outcome
LV end-diastolic volume (EDV) decrease
Time frame: 3 and 12 months after surgery
Change in end-diastolic volume of the left ventricle, assessed with EchoCG after surgical correction of aortic insufficiency
Freedom from readmission
Time frame: 12 months after surgery
Freedom from readmission due to valvular problem or heart failure-related reason
1 secondary outcome
Life quality
Time frame: Upon inclusion, 10 days post-surgery, 3 month and 12 month post-surgery
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 11 Jun 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Regurgitation and Mitral Valve Regurgitation, run by Petrovsky National Research Centre of Surgery at 2 sites in Russia.
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 13 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: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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 Eduard Charchyan, professor (+79262174114, charchmed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV end-diastolic volume (EDV) decrease (time frame: 3 and 12 months after surgery). 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?
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 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.