Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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