Angiotensin Receptor Inhibitors for Ischemic Mitral Regurgitation in Coronary Artery Disease
sacubitril/valsartan
Arterial Occlusive Diseases+5
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: June 5, 2025
Actual date on which the first participant was enrolled.This clinical trial is focused on understanding how a specific type of medication, known as angiotensin receptor/neprilysin inhibitors (ARNI), can help people with a heart condition called ischemic mitral regurgitation (IMR). IMR often occurs in patients who have coronary artery disease, a condition that affects blood flow to the heart. The study is particularly interested in patients who are undergoing a procedure called coronary artery bypass grafting (CABG), which helps improve blood flow to the heart. By exploring how ARNI can aid these patients, the study aims to find better treatment options that could improve heart function and overall health outcomes. Participants in the study will receive the ARNI medication, and researchers will monitor how this treatment impacts their heart condition, specifically looking at changes in their mitral valve function. The medication will be administered alongside their regular treatment plan as they undergo the CABG procedure. The study will carefully measure the outcomes to understand whether ARNI makes a notable difference in managing IMR, which could lead to less invasive and more effective treatment strategies for patients in the future. The study does not specify any risks or benefits, but the goal is to gather data that could lead to enhanced care for those with these heart conditions.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.220 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
China National Center for Cardiovascular Diseases
Beijing, ChinaOpen China National Center for Cardiovascular Diseases in Google Maps