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

Phase 4

Not yet recruiting

• Conditions: Coronary Artery Disease; Ischemic Mitral Regurgitation; Angiotensin Receptor/Neprilysin Inhibitor
• Interventions: Drug: sacubitril/valsartan

• Registration Number: NCT06917664
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-27
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sacubitril/valsartan therapy after isolated CABG	sacubitril/valsartan	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

China National Center for Cardiovascular Diseases; 🇨🇳 Beijing, Beijing, China