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NCT Number: NCT06917664

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

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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Key information

Conditions

Coronary Artery Disease Angiotensin Receptor/Neprilysin Inhibitor Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Ischemic Mitral Regurgitation Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Lianxin Chen, M.D.

CONTACT

[email protected]

01088322265

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 )

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.

Treatment and study plan

sacubitril/valsartan

Drug

Sacubitril/valsartan therapy after isolated CABG

Primary outcomes

  1. effective regurgitant orifice area (EROA)

    Time frame: 6 months postoperatively

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

Secondary outcomes

  1. proportion of patients with moderate or higher IMR ,LVEF,LVESV,LVESVI,LVEDV,LVEDVI

    Time frame: 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

  2. major adverse cardiovascular and cerebrovascular events (MACCE)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lianxin Chen, M.D.

CONTACT

[email protected]

010-88322265

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

  • Chinese Academy of Medical Sciences
  • Chinese Academy of Medical Sciences, Fuwai Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 8, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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