Actively Recruiting

Age: 18Years +
All Genders
ID06805253

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

Led by Petrovsky National Research Centre of Surgery · Updated on 2025-06-11

120

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

P

Petrovsky National Research Centre of Surgery

Lead Sponsor

V

Voronezh regional clinical hospital #1

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how surgical treatment for chronic aortic regurgitation affects the heart's left ventricle, especially when combined with correction of functional mitral regurgitation. The study focuses on patients with severe enlargement of the left heart chambers. It aims to assess how mitral regurgitation influences the recovery and remodeling of the left ventricle after surgery, using echocardiography and quality of life measures. Participants are grouped based on the severity of their mitral regurgitation and whether they receive mitral valve repair during surgery. The groups include patients with mild to moderate mitral regurgitation without repair, severe mitral regurgitation without repair, mild to moderate mitral regurgitation with repair, and severe mitral regurgitation with repair. This observational study does not involve additional treatments but monitors outcomes over time. Throughout the study, participants will have their left ventricle volume and function evaluated by echocardiography at 3 and 12 months after surgery. Researchers will also track hospital readmissions within 12 months and assess quality of life at inclusion, 10 days post-surgery, and at 3 and 12 months. The study is sponsored by the Petrovsky National Research Centre of Surgery and will continue until May 2030.

CONDITIONS

Brief Title

Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Planned primary elective surgery for chronic aortic regurgitation
  • Presence of functional mitral regurgitation
  • Left ventricle end-diastolic volume of 250 ml or more
Not Eligible

You will not qualify if you...

  • Infectious endocarditis
  • History of myocardial infarction
  • Need for simultaneous myocardial revascularisation
  • Acute aortic regurgitation of any cause
  • Left ventricle dilatation not caused by aortic regurgitation
  • Long-term persistent or permanent atrial fibrillation
  • Pregnancy within 12 months after surgery
  • Participation in other studies at the same time
  • Presence of implanted pacemakers
  • Refusal to sign informed consent
  • Acute coronary event within 12 months after aortic valve surgery
  • Need for resynchronization therapy or permanent right ventricular pacing within 12 months after surgery
  • Repeat heart surgery within 12 months after aortic valve surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery plus initial recovery period

Participants undergo surgical correction of aortic regurgitation and immediate care following surgery.

1 surgery visit and 1 immediate post-operative visit

Post-operative Follow-up

Duration - 12 months after surgery

Participants are monitored for left ventricular remodeling and quality of life after surgery.

Visits at 10 days, 3 months, and 12 months post-surgery

Trial Site Locations

Total: 2 locations

1

Petrovsky National Research Center of Surgery

Moscow, Russia, 119435

Actively Recruiting

2

Voronezh Regional Clinical Hospital No. 1

Voronezh, Russia, 394066

Actively Recruiting

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Research Team

E

Eduard Charchyan, professor

A

Andrei Bulynin

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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