Mitral InsufficiencyMIRACLENCT06876883
MItral Regurgitation Risk Assessment and CLinical modElling
An observational study of Mitral Insufficiency and Mitral Regurgitation (MR), run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Insufficiency, Mitral Regurgitation (MR)
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2016to 15 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with ≥ moderate mitral regurgitation (MR) during hospitalization were enrolled.
Who may be able to join
- Patients diagnosed with ≥ moderate mitral regurgitation during hospitalization.
- Aged over 18 yrs.
Who cannot join
- Patients unable to provide written consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen Univerity
Guangzhou, Guangdong, 510000
Xiaodong Zhuang, MD, +8613760755035, zhuangxd3@mail.sysu.edu.cn
About this study
Official title: MItral Regurgitation Risk Assessment and CLinical modElling (MIRACLE Study)
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
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MR | Patients with ≥ moderate mitral regurgitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death due to any cause after enrollment
Measured: Through study completion, an average of 5 years
Secondary outcomes (2)
Cardiovascular mortality
Death due to cardiovascular causes, including heart failure, myocardial infarction, fatal arrhythmia, major bleeding, stroke, sudden death and thromboembolism.
Measured: Through study completion, an average of 5 years
Heart Failure Hospitalization (HFH)
Hospitalization with the primary reason for admission as acute decompensated HF and administration of intravenous or mechanical heart failure therapies.
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start15 Jun 2016
- Primary completion15 Jun 2030 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral InsufficiencyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-dong Zhuang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876883
- Sponsor's protocol ID
- MIRACLE study
- Acronym
- MIRACLE
- Status last verified
- Aug 2025
- First submitted
- 8 Mar 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MItral Regurgitation Risk Assessment and CLinical modElling (MIRACLE Study)
- ClinicalTrials.gov ID
- NCT06876883
- Acronym / sponsor ID
- MIRACLE / MIRACLE study
- Conditions
- Mitral Insufficiency, Mitral Regurgitation (MR)
- Keywords
- mitral regurgitation, all-cause mortality, clinical modelling, cardiovascular mortality, heart failure hospitalization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 15 Jun 2030 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with MR | – | –Patients with ≥ moderate mitral regurgitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with ≥ moderate mitral regurgitation (MR) during hospitalization were enrolled.
Key inclusion criteria (2 listed)
- Patients diagnosed with ≥ moderate mitral regurgitation during hospitalization.
- Aged over 18 yrs.
Key exclusion criteria (1 listed)
- Patients unable to provide written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: Through study completion, an average of 5 years
Death due to any cause after enrollment
2 secondary outcomes
Cardiovascular mortality
Time frame: Through study completion, an average of 5 years
Heart Failure Hospitalization (HFH)
Time frame: Through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Insufficiency and Mitral Regurgitation (MR), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Zhuang, MD (+8613760755035, zhuangxd3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.