Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy

Sun Yat-sen University

Status: Enrolling

Conditions: Mitral Regurgitation; Heart Failure

Treatments: Other: The development of the prediction model; Drug: angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT06278727

SYSKY-2023-1173-01

Details and patient eligibility

About

This observational study is to develop and validate the prediction model for functional mitral regurgitation regression in heart failure patients taking GDMT. The patients diagnosed ≥2+ functional mitral regurgitation by ultrasonic cardiogram are enrolled in this study and would be clinically followed by at least one year (clinical visit at 3 months, 6 months, and 12 months), and then by when the endpoints are reached.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age>18 years old
• ≥2+ FMR
• Receiving GDMT

Exclusion criteria

• degenerative mitral regurgitation
• myocardial infarction, percutaneous coronary intervention, coronary bypass grafting surgery, cardiac resynchronization therapy, or stroke within three months prior to this study
• ≥2+ aortic stenosis or regurgitation
• previous surgical mitral valve repair or replacement
• restrictive cardiomyopthy, hypertrophic cardiomyopathy, or constrictive pericarditis
• severe heart failure (NYHA class IV) or left ventricular ejection fraction < 20%
• symptomatic hypotension affecting GDMT prescription
• severe hepatic or renal insufficiency
• life expectancy < 12 months
• Pregnancy

Trial design

270 participants in 2 patient groups

Regression group

Description:

Regression group contains the patients whose FMR regresses after taking GDMT for at least 3 months.

Treatment:

Other: The development of the prediction model

Drug: angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor

No-reaction group

Description:

No-reaction group contains the patients whose FMR has no regression by every clinical visit.

Treatment:

Drug: angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor