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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Chinese Academy of Medical Sciences | OTHER |
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This study aims to evaluate the effect of angiotensin receptor/neprilysin inhibitors (ARNI) on improving ischemic mitral regurgitation (IMR) in patients with coronary artery disease undergoing isolated coronary artery bypass grafting (CABG) through a randomized controlled clincial trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group: isolated CABG | No Intervention | ||
| Sacubitril/valsartan therapy after isolated CABG | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sacubitril/valsartan | Drug | Sacubitril/valsartan therapy after isolated CABG |
|
| Measure | Description | Time Frame |
|---|---|---|
| effective regurgitant orifice area (EROA) | Change in EROA of mitral regurgitation evaluated by echocardiography from baseline to 6 months follow-up | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with moderate or higher IMR ,LVEF,LVESV,LVESVI,LVEDV,LVEDVI | Proportion of patients with moderate or higher IMR; Left ventricular ejection fraction; Change of left ventricular end-systolic volume from baseline to 6 months follow-up; Change of left ventricular end-systolic volume index from baseline to 6 months follow-up; Change of left ventricular end-diastolic volume from baseline to 12 months follow-up; Change of left ventricular end-diastolic volume index from baseline to 12 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
1.Symptomatic hypotension and/or a SBP < 100 mmHg at screening; 2.Estimated GFR < 30 mL/min/1.73m2; 3.Serum potassium > 5 mmol/L at screening; 4.History of angioedema or unacceptable side effects while receiving ACE inhibitors or ARBs; 5.Patients receiving mitral valve intervention at the same time, or have participated in other clinical trials, or are unwilling to participate in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lianxin Chen, M.D. | Contact | 010-88322265 | chenlianx1@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhao | China National Center for Cardiovascular Diseases | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China National Center for Cardiovascular Diseases | Recruiting | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40848924 | Derived | Tiemuerniyazi X, Chen L, He L, Yang Z, Huang S, Nan Y, Song Y, Yuan X, Hu Z, Zhao D, Zhao W, Feng W. The Role of Angiotensin Receptor/Neprilysin Inhibitor in Moderate Ischemic Mitral Regurgitation After Isolated Coronary Artery Bypass Grafting (ARNI-MIMIC): Study Protocol for a Randomized Controlled Trial. Am J Cardiol. 2025 Dec 1;256:102-106. doi: 10.1016/j.amjcard.2025.08.029. Epub 2025 Aug 21. |
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| 6 months postoperatively |
| major adverse cardiovascular and cerebrovascular events (MACCE) | major adverse cardiovascular and cerebrovascular events (MACCE) defined as the composite of all-cause death, stroke, myocardial infarction, rehospitalization for heart failure, and repeat mitral valve surgery. | 6 months postoperatively |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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