Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease
1 other identifier
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 coronary-artery-disease
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2025
CompletedFirst Posted
Study publicly available on registry
April 8, 2025
CompletedStudy Start
First participant enrolled
June 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
August 27, 2025
April 1, 2025
1.5 years
March 27, 2025
August 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
effective regurgitant orifice area (EROA)
Change in EROA of mitral regurgitation evaluated by echocardiography from baseline to 6 months follow-up
6 months postoperatively
Secondary Outcomes (2)
proportion of patients with moderate or higher IMR ,LVEF,LVESV,LVESVI,LVEDV,LVEDVI
6 months postoperatively
major adverse cardiovascular and cerebrovascular events (MACCE)
6 months postoperatively
Study Arms (2)
Control group: isolated CABG
NO INTERVENTIONSacubitril/valsartan therapy after isolated CABG
EXPERIMENTALInterventions
Sacubitril/valsartan therapy after isolated CABG
Eligibility Criteria
You may qualify if:
- 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 )
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037, China
Related Publications (1)
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: 40848924DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wei Zhao
China National Center for Cardiovascular Diseases
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 8, 2025
Study Start
June 5, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
August 27, 2025
Record last verified: 2025-04