Clinical trial NCT06805253: Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
Official title: Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Regurgitation
Mitral Valve Regurgitation
Left Ventricle Dilated
Left Atrium Dilated
Systolic Left Ventricular Heart Failure
Diastolic Heart Failure
Keywords: reverse remodeling
left ventricle dilatation
mitral valve functional regurgitation recovery
left ventricle reverse remodeling
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
Collaborators: name: Voronezh regional clinical hospital #1
First posted: 2025-02-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.


Eligibility criteria: 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 \&gt;= 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

Primary outcomes:
measure: LV end-diastolic volume (EDV) decrease
timeFrame: 3 and 12 months after surgery
measure: Freedom from readmission
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Life quality
timeFrame: Upon inclusion, 10 days post-surgery, 3 month and 12 month post-surgery
Other outcomes:
measure: LV ejection fraction (EF)
timeFrame: 3 and 12 month post-surgery
measure: LV diastolic function
timeFrame: Upon inclusion, 3 month and 12 month post-surgery
measure: Left atrium volume index (LAVI)
timeFrame: Upon inclusion, 3 month and 12 month post-surgery
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky National Research Center of Surgery
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hospital No. 1
Study officials:
References: