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Recruiting NCT06917664

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

Phase IV Interventional Coronary Artery Disease Ischemic Mitral Regurgitation Angiotensin Receptor/Neprilysin Inhibitor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sacubitril/valsartan.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Ischemic Mitral Regurgitation, Angiotensin Receptor/Neprilysin Inhibitor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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.

Interventions

  • Drug sacubitril/valsartan
    Sacubitril/valsartan therapy after isolated CABG

Primary outcome measures

  • effective regurgitant orifice area (EROA) [Time frame: 6 months postoperatively]
Secondary outcome measures (2)
  • proportion of patients with moderate or higher IMR ,LVEF,LVESV,LVESVI,LVEDV,LVEDVI [Time frame: 6 months postoperatively]
  • major adverse cardiovascular and cerebrovascular events (MACCE) [Time frame: 6 months postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • China National Center for Cardiovascular Diseases — Beijing

Publications

  • Tiemuerniyazi X, Chen L, He L, Yang Z, Huang S, Nan Y, Song Y, Yuan X, Hu Z, Zhao D, Zhao W, Feng W. The Role of Angiotensin Receptor/Neprilysin Inhibitor in Moderate Ischemic Mitral Regurgitation After Isolated Coronary Artery Bypass Grafting (ARNI-MIMIC): Study Protocol for a Randomized Controlled Trial. Am J Cardiol. 2025 Dec 1;256:102-106. doi: 10.1016/j.amjcard.2025.08.029. Epub 2025 Aug 21. PMID 40848924

Identifiers

NCT: NCT06917664 · 2023-I2M-C&T-B-070

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗