Evaluating heart recovery after surgery for aortic regurgitation
Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment
This study looks at how heart surgery for aortic regurgitation helps people with heart problems feel better and recover by checking their heart function and quality of life afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Petrovsky National Research Centre of Surgery Academic / other |
| Locations | 2 sites (Moscow and 1 other locations) |
| Trial ID | NCT06805253 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of surgical correction for chronic aortic regurgitation on the reverse remodeling of the left ventricle in patients with functional mitral regurgitation. It aims to monitor changes in left ventricle volume and function post-surgery using echocardiography, while also assessing the quality of life in participants. The study focuses on patients with severe enlargement of the left heart chambers and evaluates how surgical intervention influences recovery outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years scheduled for elective surgery due to chronic aortic regurgitation with functional mitral regurgitation.
Not a fit: Patients with acute aortic regurgitation, infectious endocarditis, or those requiring simultaneous myocardial revascularization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery strategies for patients undergoing surgery for aortic regurgitation, enhancing heart function and quality of life.
How similar studies have performed: While this approach is observational, similar studies have shown promising results in understanding heart recovery post-surgery, suggesting potential for beneficial insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Moscow and 1 other locations
- Petrovsky National Research Center of Surgery — Moscow, Russia (Recruiting)
- Voronezh Regional Clinical Hospital No. 1 — Voronezh, Russia (Recruiting)
Study contacts
- Study coordinator: Eduard Charchyan, professor
- Email: charchmed@yahoo.com
- Phone: +79262174114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.