A Study on the Changes in Heart Muscle Caused by Mitral Regurgitation

Histopathological Findings of Myocardium in Patients with Primary Mitral Regurgitation: Association between Postoperative Course and Computed Tomography-Derived Extracellular Volume Fraction - Histopathological Myocardial Findings in Primary MR: Relation to Postoperative Outcomes and CT-Derived ECV

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058860

Enrollment

Registered

2025-08-22

Start date

2025-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Degenerative mitral regurgitation

Interventions

In patients with primary mitral regurgitation (degenerative mitral regurgitation, DMR) undergoing mitral valve repair, myocardial tissue will be obtained intraoperatively.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients enrolled on or after the initiation date of the present study in the existing observational cohort study entitled "A Cohort Study on the Association Between Preoperative Cardiac CT-Derived Extracellular Volume Fraction and Postoperative Left Ventricular Reverse Remodeling in Patients with Primary Mitral Regurgitation" (March 1, 2024-March 31, 2029). 2) Patients who have received a thorough explanation of this study and have provided written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients in whom intraoperative myocardial biopsy is deemed technically difficult to perform or associated with significant risk, as determined by the operating surgeon. 2) Patients judged by the investigators or the attending physician to be inappropriate for participation in this study.

Design outcomes

Primary

Measure	Time frame
Presence of Left Ventricular Reverse Remodeling Left ventricular reverse remodeling will be defined as a reduction of more than 15% in the left ventricular end-systolic volume index (LVESVi) on transthoracic echocardiography performed postoperatively compared with the preoperative value.	—

Secondary

Measure	Time frame
Correlation Between CT-ECV and Histological CVF and ECV The correlation between preoperative CT-derived extracellular volume fraction (CT-ECV) and histological collagen volume fraction (CVF) as well as histological ECV, both semi-quantitatively calculated from Masson-Trichrome-stained myocardial biopsy specimens using image analysis software, will be evaluated. In addition, the anatomical consistency between the measurement regions of CT-ECV and the corresponding biopsy sites will be examined.	—

Measure

Time frame

Correlation Between CT-ECV and Histological CVF and ECV The correlation between preoperative CT-derived extracellular volume fraction (CT-ECV) and histological collagen volume fraction (CVF) as well as histological ECV, both semi-quantitatively calculated from Masson-Trichrome-stained myocardial biopsy specimens using image analysis software, will be evaluated. In addition, the anatomical consistency between the measurement regions of CT-ECV and the corresponding biopsy sites will be examined.

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Countries

Japan

Contacts

Public ContactKato Daiki

Kobe University Hospital Department of Cardiovascular Surgery

daiki522@med.kobe-u.ac.jp0783825942

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026