Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation

NCT ID: NCT06805253

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-09

Study Completion Date

2030-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MR < 2 no MvR

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

Not applicable - observational study

Intervention Type OTHER

observation only

MR >= 2 no MvR

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

Not applicable - observational study

Intervention Type OTHER

observation only

MR < 2 MvR

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

Not applicable - observational study

Intervention Type OTHER

observation only

MR >= 2 MvR

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

Not applicable - observational study

Intervention Type OTHER

observation only

Interventions

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Not applicable - observational study

observation only

Intervention Type OTHER

Other Intervention Names

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observation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Voronezh regional clinical hospital #1

UNKNOWN

Sponsor Role collaborator

Petrovsky National Research Centre of Surgery

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Petrovsky National Research Center of Surgery

Moscow, , Russia

Site Status RECRUITING

Voronezh Regional Clinical Hospital No. 1

Voronezh, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Eduard Charchyan, professor

Role: CONTACT

+79262174114

Andrei Bulynin

Role: CONTACT

+79081339584

Facility Contacts

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Eduard Charchyan, professor

Role: primary

+79262174114

Andrei Bulynin

Role: primary

+79081339584

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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173538086

Identifier Type: -

Identifier Source: org_study_id

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