MItral Regurgitation Risk Assessment and CLinical modElling
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with ≥ moderate mitral regurgitation during hospitalization.
Aged over 18 yrs.
Disqualifiers
Patients unable to provide written consent.
Trial population
Adult patients diagnosed with ≥ moderate mitral regurgitation (MR) during hospitalization were enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 1 trial groupGroup A: Patients with MR
Trial outcomes
Primary outcomes
1
All-cause mortality
Death due to any cause after enrollment
Time frame
Through study completion, an average of 5 yearsSecondary outcomes
1
Cardiovascular mortality
Death due to cardiovascular causes, including heart failure, myocardial infarction, fatal arrhythmia, major bleeding, stroke, sudden death and thromboembolism.
Time frame
Through study completion, an average of 5 years2
Heart Failure Hospitalization (HFH)
Hospitalization with the primary reason for admission as acute decompensated HF and administration of intravenous or mechanical heart failure therapies.
Time frame
Through study completion, an average of 5 yearsSponsors and contacts
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Source ClinicalTrials.gov