Angiotensin Receptor/Neprilysin Inhibitor, Coronary Artery Disease, Ischemic Mitral Regurgitation
Conditions
Keywords
coronary artery disease, ischemic mitral regurgitation, angiotensin receptor/neprilysin inhibitor
Brief summary
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.
Interventions
DRUGsacubitril/valsartan
Sacubitril/valsartan therapy after isolated CABG
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Chinese Academy of Medical Sciences
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Fully informed and voluntarily signed informed consent; 2. Received CABG and moderate IMR was diagnosed on two consecutive preoperative transthoracic echocardiography (according to 2021 ESC/EACTS Guidance Standards )
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effective regurgitant orifice area (EROA) | 6 months postoperatively | Change in EROA of mitral regurgitation evaluated by echocardiography from baseline to 6 months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of patients with moderate or higher IMR ,LVEF,LVESV,LVESVI,LVEDV,LVEDVI | 6 months postoperatively | 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 |
| major adverse cardiovascular and cerebrovascular events (MACCE) | 6 months postoperatively | 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. |
Countries
China
Contacts
Primary ContactLianxin Chen, M.D.
Outcome results
None listed