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NCT Number: NCT06876883

MItral Regurgitation Risk Assessment and CLinical modElling

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.

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Key information

Conditions

Mitral Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation (MR) Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Sun Yat-sen Univerity

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Xiaodong Zhuang, MD

CONTACT

[email protected]

+8613760755035

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients unable to provide written consent.

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: Through study completion, an average of 5 years

    Death due to any cause after enrollment

Secondary outcomes

  1. Cardiovascular mortality

    Time frame: 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.

  2. Heart Failure Hospitalization (HFH)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaodong Zhuang, MD

CONTACT

[email protected]

+8613760755035

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

MItral Regurgitation Risk Assessment and CLinical modElling (MIRACLE Study)

Acronym: MIRACLE

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Mar 14, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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