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

NCT ID: NCT06917664

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2027-06-30

Brief Summary

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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

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Conditions

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Coronary Artery Disease Ischemic Mitral Regurgitation Angiotensin Receptor/Neprilysin Inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group: isolated CABG

Group Type NO_INTERVENTION

No interventions assigned to this group

Sacubitril/valsartan therapy after isolated CABG

Group Type EXPERIMENTAL

sacubitril/valsartan

Intervention Type DRUG

Sacubitril/valsartan therapy after isolated CABG

Interventions

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sacubitril/valsartan

Sacubitril/valsartan therapy after isolated CABG

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Zhao

Role: STUDY_CHAIR

China National Center for Cardiovascular Diseases

Locations

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China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lianxin Chen, M.D.

Role: CONTACT

010-88322265

Facility Contacts

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Lianxin Chen, M.D.

Role: primary

01088322265

References

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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 Aug 21;256:102-106. doi: 10.1016/j.amjcard.2025.08.029. Online ahead of print.

Reference Type DERIVED
PMID: 40848924 (View on PubMed)

Other Identifiers

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2023-I2M-C&T-B-070

Identifier Type: -

Identifier Source: org_study_id

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