Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation

NCT06805253 | Recruiting

• 1 other identifier: 173538086
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• LV end-diastolic volume (EDV) decrease

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

  3 and 12 months after surgery

• Freedom from readmission

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

  12 months after surgery

Secondary Outcomes (1)

• Life quality

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

Other Outcomes (3)

• LV ejection fraction (EF)

  3 and 12 month post-surgery

• LV diastolic function

  Upon inclusion, 3 month and 12 month post-surgery

• Left atrium volume index (LAVI)

  Upon inclusion, 3 month and 12 month post-surgery

Study Arms (4)

MR < 2 no MvR

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

Other: Not applicable - observational study

MR >= 2 no MvR

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

Other: Not applicable - observational study

MR < 2 MvR

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

Other: Not applicable - observational study

MR >= 2 MvR

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

Other: Not applicable - observational study

Interventions

Not applicable - observational study OTHER

observation only

Also known as: observation

MR < 2 MvR; MR < 2 no MvR; MR >= 2 MvR; MR >= 2 no MvR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery: lead
• Voronezh regional clinical hospital #1: collaborator

Study Sites (2)

Petrovsky National Research Center of Surgery

Moscow, 119435, Russia

RECRUITING

Voronezh Regional Clinical Hospital No. 1

Voronezh, 394066, Russia

RECRUITING

MeSH Terms

Conditions

Aortic Valve Insufficiency; Mitral Valve Insufficiency; Heart Failure, Diastolic

Interventions

Observation

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Heart Failure

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Eduard Charchyan, professor

CONTACT

+79262174114; charchmed@yahoo.com

Andrei Bulynin

CONTACT

+79081339584; bandrew@inbox.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: February 3, 2025
• Study Start: May 9, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

RU (2)