MItral Regurgitation Risk Assessment and CLinical modElling

Recruiting

• Conditions: Mitral Insufficiency; Mitral Regurgitation (MR)

• Registration Number: NCT06876883
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Mitral regurgitation (MR) is a common valvular heart disease worldwide, and untreated severe MR is associated with an elevated risk of heart failure and mortality. According to causes, MR could be divided into primary or secondary MR. The risk factors of mortality or heart failure hospitalization in different types of MR patients are under intensive investigation.

MItral Regurgitation risk Assessment and CLinical modElling (MIRACLE) study is a prospective cohort study including adult patients diagnosed with ≥ moderate MR during hospitalization. Comprehensive echocardiographic examination was conducted at baseline evaluating valvular heart disease severity, atrial and ventricular systolic/diastolic function, pulmonary artery systolic pressure (PASP), etc. We aim to evaluate the prognostic risk factors of patients with MR and construct a prognostic clinical model to guide clinical decision-making.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-15
• Study First Submitted: 2025-03-08
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-14
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-09-05
• Primary Completion: 2030-06-15
• Study Completion: 2030-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patients diagnosed with ≥ moderate mitral regurgitation during hospitalization.
• Aged over 18 yrs.

Exclusion Criteria

• Patients unable to provide written consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	Through study completion, an average of 5 years	Death due to any cause after enrollment

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality	Through study completion, an average of 5 years	Death due to cardiovascular causes, including heart failure, myocardial infarction, fatal arrhythmia, major bleeding, stroke, sudden death and thromboembolism.
Heart Failure Hospitalization (HFH)	Through study completion, an average of 5 years	Hospitalization with the primary reason for admission as acute decompensated HF and administration of intravenous or mechanical heart failure therapies.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen Univerity; 🇨🇳 Guangzhou, Guangdong, China