Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062959) titled 'Cardiomyopathy HeterOgeneity and Risk stratification through Deep phenotyping (CHORD study)' on Oct. 15.

Study Type: Observational

Primary Sponsor: Institute - Keio University School of Medicine

Condition: Condition - non-dilated left ventricular cardiomyopathy Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - The aim of this study is to comprehensively characterize the natural history and disease heterogeneity of NDLVC through deep phenotyping integrating clinical, imaging, genetic, and multi-omics data, and to scientifically validate its relevance and underlying structure as a novel phenotypic category proposed by the 2023 ESC Guidelines. Specifically, this study aims to: 1. Characterize the natural history and clinical outcomes of NDLVC by integrating a 5-year prospective follow-up with a large-scale retrospective cohort; 2. Identify and reclassify distinct phenotypes and endotypes within NDLVC; and 3. Characterize dynamic disease processes based on longitudinal changes in multi-omics and imaging data. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Presence of late gadolinium enhancement (LGE) on cardiac magnetic resonance imaging (CMR), irrespective of LVEF 2. Presence of left ventricular systolic dysfunction on transthoracic echocardiography 3. Left ventricular end-diastolic diameter within the upper limit of normal: <58 mm in men and <52 mm in women (no adjustment for body size required) Key exclusion criteria - 1. Patients diagnosed with primary cardiomyopathy (dilated, hypertrophic, restrictive, or arrhythmogenic right ventricular cardiomyopathy) 2. Patients diagnosed with secondary cardiomyopathy (e.g., cardiac amyloidosis, cardiac sarcoidosis, mitochondrial disease, Fabry disease, peripartum cardiomyopathy, post-myocarditis cardiomyopathy, drug-induced cardiomyopathy, or alcoholic cardiomyopathy) 3. Patients with significant coronary artery stenosis (50% or greater in the left main coronary artery or 75% or greater in any other major coronary artery), a history of myocardial infarction, or prior percutaneous coronary intervention or coronary artery bypass grafting 4. Patients with severe valvular heart disease 5. Patients with congenital heart disease 6. Patients with pulmonary hypertension other than Group 2 pulmonary hypertension 7. Patients with severe hepatic dysfunction or liver cirrhosis 8. Patients with severe renal dysfunction or those receiving dialysis 9. Patients with active cancer or a history of anthracycline therapy (use of other anticancer agents is permitted) 10. Patients with a life expectancy of less than 1 year 11. Patients deemed unsuitable for participation in the study by the principal investigator or co-investigators. Target Size - 5000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 16 Day Date of IRB - 2026 Year 02 Month 27 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2033 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071987

Disclaimer: Curated by HT Syndication.