Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Not applicable - observational study.
- Who it may be relevant to
- Registry conditions: Aortic Valve Regurgitation, Mitral Valve Regurgitation, Left Ventricle Dilated, Left Atrium Dilated. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment
Overview
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.
Interventions
- Other Not applicable - observational study
observation only
Primary outcome measures
- LV end-diastolic volume (EDV) decrease [Time frame: 3 and 12 months after surgery]
- Freedom from readmission [Time frame: 12 months after surgery]
Secondary outcome measures (1)
- Life quality [Time frame: Upon inclusion, 10 days post-surgery, 3 month and 12 month post-surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 2 centers
- Petrovsky National Research Center of Surgery — Moscow
- Voronezh Regional Clinical Hospital No. 1 — Voronezh
Identifiers
NCT: NCT06805253 · 173538086