Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully informed and voluntarily signed informed consent;

Received CABG and moderate IMR was diagnosed on two consecutive preoperative transthoracic echocardiography (according to 2021 ESC/EACTS Guidance Standards )

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • sacubitril/valsartan

    Drug

    Sacubitril/valsartan therapy after isolated CABG

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Control group: isolated CABGNo intervention 0 interventions
Group B: Sacubitril/valsartan therapy after isolated CABGExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

effective regurgitant orifice area (EROA)

Change in EROA of mitral regurgitation evaluated by echocardiography from baseline to 6 months follow-up

Time frame
6 months postoperatively

Secondary outcomes

1

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

Time frame
6 months postoperatively
2

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.

Time frame
6 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator

Chinese Academy of Medical Sciences

Collaborator