Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062102) titled 'Association Between Reverse Remodeling and Electrocardiogram Normalization in Heart Failure with Reduced Ejection Fraction' on July 1.
Study Type:
Observational
Primary Sponsor:
Institute - Iwate Medical University
Condition:
Condition - Heart failure with reduced ejection fraction
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the association between normalization or persistence of abnormalities on 12-lead electrocardiography at the time of left ventricular ejection fraction improvement and subsequent heart failure worsening events and death among patients with heart failure with reduced ejection fraction who experienced reverse remodeling. This study aims to identify electrocardiographic findings useful for risk stratification after reverse remodeling.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who visited the Department of Cardiology at Iwate Medical University Hospital or participating institutions between April 1, 2013 and December 31, 2024, were diagnosed with heart failure with reduced ejection fraction, and received treatment. Heart failure with reduced ejection fraction is defined as LVEF <40% according to the Japanese Circulation Society guideline for heart failure.
Key exclusion criteria - 1) Patients who underwent invasive treatment for ischemic heart disease. 2) Patients with severe primary valvular heart disease. 3) Patients receiving maintenance dialysis. 4) Patients after implantation of a permanent pacemaker. 5) Patients who declined participation through the opt-out process.
Target Size - 2500
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2026 Year 06 Month 11 Day
Date of IRB - 2026 Year 06 Month 18 Day
Anticipated trial start date - 2026 Year 06 Month 18 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071060
Disclaimer: Curated by HT Syndication.