Aortic Valve Regurgitation, Diastolic Heart Failure, Left Atrium Dilated, Left Ventricle Dilated, Mitral Valve Regurgitation, Systolic Left Ventricular Heart Failure
Conditions
Keywords
reverse remodeling, left ventricle dilatation, mitral valve functional regurgitation recovery, left ventricle reverse remodeling
Brief 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. 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.
Interventions
observation only
Sponsors
Voronezh regional clinical hospital #1
Petrovsky National Research Centre of Surgery
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LV end-diastolic volume (EDV) decrease | 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 | 12 months after surgery | Freedom from readmission due to valvular problem or heart failure-related reason |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Life quality | Upon inclusion, 10 days post-surgery, 3 month and 12 month post-surgery | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| LV ejection fraction (EF) | 3 and 12 month post-surgery | Left ventricle ejection fraction, assessed with EchoCG |
| LV diastolic function | Upon inclusion, 3 month and 12 month post-surgery | Left ventricle diastolic function, assessed with EchoCG |
| Left atrium volume index (LAVI) | Upon inclusion, 3 month and 12 month post-surgery | Left atrium volume indexed to body surface area, assessed with EchoCG |
Countries
Russia
Contacts
Primary ContactEduard Charchyan, professor
Backup ContactAndrei Bulynin
Outcome results
None listed