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Not yet recruitingNCT07230756China-IMRUpdated Nov 17, 2025

Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China

An observational study in Ischemic Mitral Regurgitation and Coronary Heart Disease (CHD), sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by China National Center for Cardiovascular Diseases · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,000
Ages
18 Years and older
Sex
All
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Study summary

This project will rely on the established multi-center cooperation platform for total valve disease and based on the Carpentier classification, which is newly proposed and widely recognized by the academic community, and will specifically target the population with coronary heart disease combined with Ischemic Mitral Regurgitation(IMR) to conduct a nationwide, multi-center, single valve disease, prospective cohort. Research. From November 2025 to December 2025, 6,000 patients with coronary heart disease combined with moderate or above IMR were consecutively selected from outpatients or inpatients in 21 regional medical centers across the country, and clinical characteristics, imaging data, and serology were collected. Information, drug/surgical intervention status and clinical outcome indicators were included in the clinical follow-up at baseline, 3 months, 6 months, 12 months and 24 months respectively. The main research objectives are to describe the disease characteristics, treatment status and clinical outcomes of coronary heart disease patients with IMR; to evaluate the current application status of GDMT strategies in IMR diagnosis and treatment practice and its impact on mid- and long-term prognosis. The secondary research objectives are to identify factors affecting prognosis, construct a risk stratification model for mid- and long-term prognosis, and discover new molecular markers.

This project will for the first time construct the world's largest clearly defined cohort of coronary heart disease combined with IMR. Its research results can provide high-quality data and decision-making basis for precise diagnosis and treatment of IMR populations. Therefore, this project has important scientific research value and clinical guidance significance.

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Conditions studied

  • Ischemic Mitral Regurgitation
  • Coronary Heart Disease (CHD)

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In context

Coronary Disease

2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 460 across 953 observational studies indexed under Coronary Disease.

Browse Coronary Disease studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

People with coronary heart disease combined with ischemic mitral regurgitation

Inclusion criteria

  • Age ≥18 years, secondary mitral regurgitation discovered during outpatient visit or hospitalization;
  • Have definite coronary heart disease
  • Cardiac ultrasound: consistent with mitral regurgitation caused by myocardial ischemia or myocardial infarction:

    1. Segmental wall motion abnormality or
    2. Mitral regurgitation is consistent with Carpentier type IIIb (eccentric regurgitation)
  • Cardiac ultrasound prompts: moderate or above ischemic mitral regurgitation

Exclusion criteria

Exclusion Criteria:

  • Patients within the past year or currently participating in other clinical studies;
  • Primary mitral regurgitation (such as mitral valve prolapse, perforation, chordae tendineae rupture, etc.);
  • Dilated cardiomyopathy, hypertrophic cardiomyopathy and other diseases;
  • Moderate and above aortic stenosis/regurgitation, mitral stenosis, tricuspid stenosis, etc.;
  • Patients who have undergone cardiac valve intervention/surgery.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • GDMT Group
  • Non-GDMT Group
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What researchers measure

Primary outcomes

  1. Composite endpoint of heart failure hospitalization and all-cause death

    Time to first occurrence of either hospitalization for heart failure or death from any cause, whichever occurs first.

    Time frame: 3, 6, 12, 24 months

Secondary outcomes

  1. Change in mitral regurgitation severity

    Change in mitral regurgitation (MR) grade from baseline to 24 months as assessed by echocardiography, measured using standard semiquantitative grading (none, mild, moderate, severe).

    Time frame: 3 month, 6 month, 12 month, 24 month

  2. All-cause mortality

    Incidence of death due to any cause during the follow-up period

    Time frame: 3 month, 6 month, 12 month, 24 month

  3. Hospitalization for heart failure

    Incidence of unplanned hospital admission primarily for management of heart failure symptoms.

    Time frame: 3, 6, 12, 24 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07230756
Lead sponsor
China National Center for Cardiovascular Diseases
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Nov 10, 2025 (estimated)
Primary completion
Sep 30, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Nov 17, 2025

Study contacts

Erli Zhang, MD, PhD
Contact
zhangerli@fuaihospital.org
+86-18500853301
Erli Zhang, MD, PhD
principal investigator · China National Center for Cardiovascular Diseases

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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