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

June 5, 2025 updated by: Petrovsky National Research Centre of Surgery

Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119435
        • Recruiting
        • Petrovsky National Research Center of Surgery
        • Contact:
      • Voronezh, Russian Federation, 394066
        • Recruiting
        • Voronezh Regional Clinical Hospital No. 1
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
observation only
Other Names:
  • observation
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
observation only
Other Names:
  • observation
MR < 2 MvR
Patients with functional mitral regurgitation grade 0-1, 1 and 1-2, mitral valve repaired
Other: Not applicable - observational study
observation only
Other Names:
  • observation
MR >= 2 MvR
Patients with mitral valve functional regurgitation of grade 2 and more severe, mitral valve repaired
Other: Not applicable - observational study
observation only
Other Names:
  • observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LV end-diastolic volume (EDV) decrease
Time Frame: 3 and 12 months after surgery
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
Time Frame: 12 months after surgery
Freedom from readmission due to valvular problem or heart failure-related reason
12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life quality
Time Frame: Upon inclusion, 10 days post-surgery, 3 month and 12 month post-surgery
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).
Upon inclusion, 10 days post-surgery, 3 month and 12 month post-surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
LV ejection fraction (EF)
Time Frame: 3 and 12 month post-surgery
Left ventricle ejection fraction, assessed with EchoCG
3 and 12 month post-surgery
LV diastolic function
Time Frame: Upon inclusion, 3 month and 12 month post-surgery
Left ventricle diastolic function, assessed with EchoCG
Upon inclusion, 3 month and 12 month post-surgery
Left atrium volume index (LAVI)
Time Frame: Upon inclusion, 3 month and 12 month post-surgery
Left atrium volume indexed to body surface area, assessed with EchoCG
Upon inclusion, 3 month and 12 month post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Petrovsky National Research Centre of Surgery

Collaborators

Voronezh regional clinical hospital #1

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2024

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 173538086

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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