MItral Regurgitation Risk Assessment and CLinical modElling

NCT ID: NCT06876883

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-15

Study Completion Date

2030-06-15

Brief Summary

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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

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Conditions

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Mitral Insufficiency Mitral Regurgitation (MR)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with MR

Patients with ≥ moderate mitral regurgitation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients unable to provide written consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Xiao-dong Zhuang

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Sun Yat-sen Univerity

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaodong Zhuang, MD

Role: CONTACT

+8613760755035

Facility Contacts

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Xiaodong Zhuang, MD

Role: primary

+8613760755035

Other Identifiers

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MIRACLE study

Identifier Type: -

Identifier Source: org_study_id

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