A Registry Study of Biomarkers in Mitral Valve Disease (BIOMS-MVD)

Recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT05141292
• Lead Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases

Brief Summary

The registry study aims to discover the prognostic value of bio-markers in mitral valve disease

Detailed Description

The purpose of this study is to investigate the prognostic value of biomarkers in mitral valve disease.Patients with confirmed diagnosis of mitral valve disease are enrolled.The primary outcome is all-cause mortality based on the death certificates. The secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records.

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-02
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-02-04
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Patients clinically diagnosed with mitral valve disease in Beijing Anzhen Hospital from April 2016 to December 2019
• The operator performs more than 25 mitral valve operations per year / the operator unit has surgeons who complete 50 operations per year

Exclusion Criteria

• Age ≤ 18 years
• Failure to obtain medical records and ultrasound data
• Refuse follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of death (all cause)	1 years of follow-up	Number of death within 2 years of discharge

Secondary Outcome Measures

Name	Time	Method
Number of rehospitalizations	1 years of follow-up	Number of heart failure related hospitalization within 1 years of discharge

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China