ClinicalTrials.gg
RecruitingNCT06805253ORMIXUpdated Jun 11, 2025

Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation

An observational study in Aortic Valve Regurgitation, Mitral Valve Regurgitation and Left Ventricle Dilated, sponsored by Petrovsky National Research Centre of Surgery. Recruiting at 2 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Petrovsky National Research Centre of Surgery · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Aortic Valve Insufficiency

169 studies on the registry are indexed under Aortic Valve Insufficiency; 54 are open to participants now.

This study's planned enrollment of 120 is below the median of 224 across 74 observational studies indexed under Aortic Valve Insufficiency.

Browse Aortic Valve Insufficiency studies →

Lead sponsor

Petrovsky National Research Centre of Surgery is the lead sponsor of 18 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

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05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNot applicable - observational study

    observation only

    Also known as: observation

06

What researchers measure

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

07

Study locations

2 of 2 sites recruiting
  • Petrovsky National Research Center of Surgery
    Moscow, 119435, Russian Federation
    Recruiting
  • Voronezh Regional Clinical Hospital No. 1
    Voronezh, 394066, Russian Federation
    Recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06805253
Lead sponsor
Petrovsky National Research Centre of Surgery
Collaborators
Voronezh regional clinical hospital #1
Responsible party
Sponsor
First posted
Feb 3, 2025
Start date
May 9, 2024
Primary completion
May 2029 (estimated)
Completion
May 2030 (estimated)
Last update
Jun 11, 2025

Study contacts

Eduard Charchyan, professor
Contact
charchmed@yahoo.com
+79262174114
Andrei Bulynin
Contact
bandrew@inbox.ru
+79081339584

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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