MItral Regurgitation Risk Assessment and CLinical modElling

MItral Regurgitation Risk Assessment and CLinical modElling (MIRACLE Study)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06876883

Acronym

MIRACLE

Enrollment

2000

Registered

2025-03-14

Start date

2016-06-15

Completion date

2030-06-15

Last updated

2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Insufficiency, Mitral Regurgitation (MR)

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patients unable to provide written consent.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactXiaodong Zhuang, MD

zhuangxd3@mail.sysu.edu.cn+8613760755035

Outcome results