Sacubitril/valsartan after bypass to treat moderate ischemic mitral regurgitation
Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease
This trial will test whether the drug sacubitril/valsartan can reduce moderate ischemic mitral regurgitation in people with coronary artery disease who have had isolated coronary artery bypass grafting (CABG).
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06917664 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled trial testing sacubitril/valsartan (an angiotensin receptor–neprilysin inhibitor) given after isolated CABG in patients with moderate ischemic mitral regurgitation. Patients are enrolled if they had moderate IMR confirmed on two consecutive preoperative transthoracic echocardiograms and meet safety labs and blood pressure criteria. The main outcome is change in mitral regurgitation severity and related cardiac remodeling measured by echocardiography over follow-up. Key exclusions include symptomatic hypotension, severe renal dysfunction, high serum potassium, history of angioedema with RAAS blockers, or concurrent mitral valve interventions.
Who should consider this trial
Good fit: Ideal candidates are people with coronary artery disease who underwent isolated CABG and had moderate ischemic mitral regurgitation confirmed on two preoperative echocardiograms and who meet blood pressure and lab safety limits.
Not a fit: Patients with symptomatic low blood pressure, estimated GFR under 30 mL/min/1.73 m2, serum potassium over 5 mmol/L, a history of angioedema with ACE inhibitors/ARBs, or those receiving concurrent mitral valve intervention are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the treatment could reduce mitral regurgitation severity and improve heart function and symptoms, possibly avoiding additional mitral procedures.
How similar studies have performed: ARNI therapy (sacubitril/valsartan) has shown clear benefits in heart failure and some promise for reverse remodeling and reducing functional mitral regurgitation, but its specific use to treat ischemic MR after CABG is relatively novel and less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- China National Center for Cardiovascular Diseases — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Lianxin Chen, M.D.
- Email: chenlianx1@163.com
- Phone: 010-88322265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.