About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Infectious endocarditis
History of myocardial infarction
Indications on simultaneous myocardial revascularisation
Acute aortic regurgitation of any etiology
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not applicable - observational study
Other interventionobservation only
Treatment groups
Trial outcomes
Primary outcomes
LV end-diastolic volume (EDV) decrease
Change in end-diastolic volume of the left ventricle, assessed with EchoCG after surgical correction of aortic insufficiency
Freedom from readmission
Freedom from readmission due to valvular problem or heart failure-related reason
Secondary outcomes
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).
Other outcomes
LV ejection fraction (EF)
Left ventricle ejection fraction, assessed with EchoCG
LV diastolic function
Left ventricle diastolic function, assessed with EchoCG
Left atrium volume index (LAVI)
Left atrium volume indexed to body surface area, assessed with EchoCG
Sponsors and contacts
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Petrovsky National Research Centre of Surgery
Lead sponsor
Voronezh regional clinical hospital #1
Collaborator