Tokyo, June 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062036) titled 'A study to develop an ultrasound-based method for estimating heart relaxation and filling pressure in Japanese patients' on June 23.

Study Type: Observational

Primary Sponsor: Institute - Ehime University Graduate School of Medicine

Condition: Condition - Heart disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This multicenter prospective observational study aims to clarify the associations between echocardiographic parameters and invasively measured left ventricular filling pressure obtained by cardiac catheterization, and to develop echocardiography-based diagnostic algorithms for left ventricular diastolic function and filling pressure that are appropriate for Japanese patients. Separate prediction algorithms will be developed for patients in sinus rhythm and those with atrial fibrillation because of differences in hemodynamics and available echocardiographic parameters. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Age 18 years or older. 2. Patients undergoing clinically indicated right heart catheterization (or left heart catheterization) and transthoracic echocardiography within 6 hours for evaluation of cardiovascular disease. Examination timing will not be adjusted for research purposes. Any treatment between the examinations, including diuretics, intravenous fluids, or oxygen, will be recorded. 3. Patients with atrial fibrillation are eligible. 4. Written informed consent is obtained from the participant. Key exclusion criteria - 1. Severe cardiac disease requiring mechanical circulatory support or catecholamine administration. 2. Previous heart transplantation. 3. Within 1 month after cardiovascular surgery. 4. Poor echocardiographic image quality or inability to obtain required images. 5. Maintenance dialysis. 6. Severe regurgitant valvular heart disease. Target Size - 1200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 25 Day Date of IRB - 2026 Year 06 Month 08 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2029 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070985

Disclaimer: Curated by HT Syndication.