Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation (NCT06805253) | Clinical Trial Compass
RecruitingNot Applicable
Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
Russia120 participantsStarted 2024-05-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
LV end-diastolic volume (EDV) decrease
Timeframe: 3 and 12 months after surgery
2
Freedom from readmission
Timeframe: 12 months after surgery
Trial details
NCT IDNCT06805253
SponsorPetrovsky National Research Centre of Surgery