MItral Regurgitation Risk Assessment and CLinical modElling (MIRACLE)

MItral Regurgitation Risk Assessment and CLinical modElling (MIRACLE Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Insufficiency; Mitral Regurgitation (MR)

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Xiaodong Zhuang, MD; Phone Number: +8613760755035; Email: zhuangxd3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen Univerity
      • Contact: Xiaodong Zhuang, MD; Phone Number: +8613760755035; Email: zhuangxd3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with ≥ moderate mitral regurgitation (MR) during hospitalization were enrolled.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients unable to provide written consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with MR; Patients with ≥ moderate mitral regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Death due to any cause after enrollment	Through study completion, an average of 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2016
• Primary Completion (Estimated): June 15, 2030
• Study Completion (Estimated): June 15, 2030

Study Registration Dates

• First Submitted: March 8, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 14, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: mitral regurgitation; all-cause mortality; cardiovascular mortality; heart failure hospitalization; clinical modelling
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: MIRACLE study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No