MItral Regurgitation Risk Assessment and CLinical modElling

NCT06876883 | Recruiting DMC

• 1 other identifier: MIRACLE study
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Insufficiency; Mitral Regurgitation (MR)

Keywords

mitral regurgitation; all-cause mortality; clinical modelling; cardiovascular mortality; heart failure hospitalization

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Death due to any cause after enrollment

  Through study completion, an average of 5 years

Secondary Outcomes (2)

• Cardiovascular mortality

  Through study completion, an average of 5 years

• Heart Failure Hospitalization (HFH)

  Through study completion, an average of 5 years

Study Arms (1)

Patients with MR

Patients with ≥ moderate mitral regurgitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients unable to provide written consent.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen Univerity

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Xiaodong Zhuang, MD

CONTACT

+8613760755035; zhuangxd3@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 14, 2025
• Study Start: June 15, 2016
• Primary Completion (Estimated): June 15, 2030
• Study Completion (Estimated): June 15, 2030
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

CN (1)