NCT06805253Recruiting
Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment
Source: ClinicalTrials.gov · Last updated 11 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 18 Oct 2024
- Start date
- 9 May 2024
- Primary completion date
- 31 May 2029
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Diseases
- Heart failure
- NCT number
- NCT06805253
What you commit to
- Study type: Observational
- Planned participants: 120
- From 9 May 2024 to the primary completion date, 31 May 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed dilatation of the left ventricle, not associated with the development of aortic regurgitation
- Pregnancy in the first 12 months after surgery
- 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
Other illness
- History of myocardial infarction
- Indications on simultaneous myocardial revascularisation
- Re-do cardiac surgery for any reason within 12 months after aortic valve surgery
Other
- Infectious endocarditis
- Acute aortic regurgitation of any etiology
- Long-term persistent or permanent form of atrial fibrillation
- Simultaneous participation in other studies
- Presence of implanted pacemakers
- Refusal to sign informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Petrovsky National Research Center of Surgery Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| Voronezh Regional Clinical Hospital No. 1 Coordinator of this site? Confirm its status | Voronezh | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.