Tokyo, March 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061045) titled 'Development and Validation of the Tokyo Heart Score (Provisional) within the Tokyo Comprehensive Stroke and Cardiovascular Disease Support Center' on March 24.

Study Type: Observational

Primary Sponsor: Institute - Sakakibara Heart Institute

Condition: Condition - Eligible participants are patients receiving outpatient or inpatient care for cardiovascular disease who have been provided with an explanation of the study and have given appropriate informed consent. Cardiovascular conditions include a broad spectrum of heart diseases, including heart failure stages A through D. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to develop a novel, freely available, Japan-specific quality-of-life (QOL) instrument for cardiovascular disease, the Tokyo Heart Score (provisional), as part of the Tokyo Comprehensive Support Center for Stroke and Cardiovascular Diseases model project, and to evaluate its validity and practical utility.

In the validation phase, the Tokyo Heart Score will be assessed in relation to established measures, including the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol-5 Dimensions (EQ-5D), as well as completion rates and response burden, to determine its feasibility and applicability in real-world clinical practice. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Patients with cardiovascular disease under care in a cardiology department who are able to complete the questionnaire. Key exclusion criteria - - Individuals who do not provide consent to participate in the study, or those deemed inappropriate for participation by the principal investigator.

- No healthy volunteers will be recruited. Target Size - 500

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 09 Day Date of IRB - 2025 Year 06 Month 09 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069854

Disclaimer: Curated by HT Syndication.