Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation (ORMIX)

Petrovsky National Research Centre of Surgery

Status: Enrolling

Conditions: Mitral Valve Regurgitation; Diastolic Heart Failure; Aortic Valve Regurgitation; Left Atrium Dilated; Left Ventricle Dilated; Systolic Left Ventricular Heart Failure

Treatments: Other: Not applicable - observational study

Study type: Observational

Funder types: Other

Identifiers

NCT06805253

173538086

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 4 patient groups

MR < 2 no MvR

Description:

Patients with functional mitral regurgitation grade 0-1, 1 and 1-2 without mitral valve repair (MvR)

Treatment:

Other: Not applicable - observational study

MR >= 2 no MvR

Description:

Patients with mitral valve functional regurgitation of grade 2 and more severe without mitral valve repair

Treatment:

Other: Not applicable - observational study

MR < 2 MvR

Description:

Patients with functional mitral regurgitation grade 0-1, 1 and 1-2, mitral valve repaired

Treatment:

Other: Not applicable - observational study

MR >= 2 MvR

Description:

Patients with mitral valve functional regurgitation of grade 2 and more severe, mitral valve repaired

Treatment:

Other: Not applicable - observational study