Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Voronezh regional clinical hospital #1 | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR < 2 no MvR | Patients with functional mitral regurgitation grade 0-1, 1 and 1-2 without mitral valve repair (MvR) |
| |
| MR >= 2 no MvR | Patients with mitral valve functional regurgitation of grade 2 and more severe without mitral valve repair |
| |
| MR < 2 MvR | Patients with functional mitral regurgitation grade 0-1, 1 and 1-2, mitral valve repaired |
| |
| MR >= 2 MvR | Patients with mitral valve functional regurgitation of grade 2 and more severe, mitral valve repaired |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable - observational study | Other | observation only |
|
| Measure | Description | Time Frame |
|---|---|---|
| LV end-diastolic volume (EDV) decrease | Change in end-diastolic volume of the left ventricle, assessed with EchoCG after surgical correction of aortic insufficiency | 3 and 12 months after surgery |
| Freedom from readmission | Freedom from readmission due to valvular problem or heart failure-related reason | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Upon inclusion, 10 days post-surgery, 3 month and 12 month post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| LV ejection fraction (EF) | Left ventricle ejection fraction, assessed with EchoCG | 3 and 12 month post-surgery |
| LV diastolic function | Left ventricle diastolic function, assessed with EchoCG |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduard Charchyan, professor | Contact | +79262174114 | charchmed@yahoo.com | |
| Andrei Bulynin | Contact | +79081339584 | bandrew@inbox.ru |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Petrovsky National Research Center of Surgery | Recruiting | Moscow | 119435 | Russia |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2024 | Feb 3, 2025 |
Not provided
Not provided
Not provided
Not provided
| Upon inclusion, 3 month and 12 month post-surgery |
| Left atrium volume index (LAVI) | Left atrium volume indexed to body surface area, assessed with EchoCG | Upon inclusion, 3 month and 12 month post-surgery |
| Voronezh Regional Clinical Hospital No. 1 | Recruiting | Voronezh | 394066 | Russia |
|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| D008944 | Mitral Valve Insufficiency |
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006333 | Heart Failure |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided