Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPetrovsky National Research Centre of Surgery

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Not applicable - observational study

    Other intervention

    observation only

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: MR < 2 no MvR1 intervention
Group B: MR >= 2 no MvR1 intervention
Group C: MR < 2 MvR1 intervention
Group D: MR >= 2 MvR1 intervention

Trial outcomes

Primary outcomes

1

LV end-diastolic volume (EDV) decrease

Change in end-diastolic volume of the left ventricle, assessed with EchoCG after surgical correction of aortic insufficiency

Time frame
3 and 12 months after surgery
2

Freedom from readmission

Freedom from readmission due to valvular problem or heart failure-related reason

Time frame
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).

Time frame
Upon inclusion, 10 days post-surgery, 3 month and 12 month post-surgery

Other outcomes

1

LV ejection fraction (EF)

Left ventricle ejection fraction, assessed with EchoCG

Time frame
3 and 12 month post-surgery
2

LV diastolic function

Left ventricle diastolic function, assessed with EchoCG

Time frame
Upon inclusion, 3 month and 12 month post-surgery
3

Left atrium volume index (LAVI)

Left atrium volume indexed to body surface area, assessed with EchoCG

Time frame
Upon inclusion, 3 month and 12 month post-surgery

Sponsors and contacts

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Petrovsky National Research Centre of Surgery

Lead sponsor

Voronezh regional clinical hospital #1

Collaborator