Tokyo, Aug. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058860) titled 'A Study on the Changes in Heart Muscle Caused by Mitral Regurgitation' on Aug. 22.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kobe University

Condition: Condition - Degenerative mitral regurgitation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The present study aims to elucidate the histopathological characteristics of myocardial tissue, including fibrosis, using left atrial and left ventricular biopsy specimens obtained during mitral valve repair in patients with degenerative mitral regurgitation (DMR). Furthermore, it seeks to investigate how these histological findings are associated with postoperative left ventricular function and clinical outcomes such as the maintenance of sinus rhythm. In addition, by examining the correlation between computed tomography-derived extracellular volume fraction (CT-ECV), a noninvasive imaging modality, and histological markers of myocardial fibrosis, this study aims to clarify the clinical utility of CT-ECV. Basic objectives2 - Others

Intervention: Interventions/Control_1 - In patients with primary mitral regurgitation (degenerative mitral regurgitation, DMR) undergoing mitral valve repair, myocardial tissue will be obtained intraoperatively.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 01 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2030 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067313

Disclaimer: Curated by HT Syndication.