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

Phase 4RecruitingNCT06917664

China National Center for Cardiovascular Diseases220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

220

Conditions

Coronary Artery Disease Ischemic Mitral Regurgitation Angiotensin Receptor/Neprilysin Inhibitor

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts