NCT06805253 Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
| NCT ID | NCT06805253 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Petrovsky National Research Centre of Surgery |
| Condition | Aortic Valve Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-05-09 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-05-09 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06805253 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06805253 currently recruiting?
Yes, NCT06805253 is actively recruiting participants. Contact the research team at charchmed@yahoo.com for enrollment information.
Where is the NCT06805253 trial being conducted?
This trial is being conducted at Moscow, Russia, Voronezh, Russia.
Who is sponsoring the NCT06805253 clinical trial?
NCT06805253 is sponsored by Petrovsky National Research Centre of Surgery. The trial plans to enroll 120 participants.