Tokyo, Jan. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060357) titled 'Clinical Utility of Respiratory Stability Time for Early Identification of Worsening Heart Failure: A Multicenter Regional Collaboration Study' on Jan. 15.

Study Type: Observational

Primary Sponsor: Institute - Kawaguchi Cardiovascular and Respiratory Hospital

Condition: Condition - Heart Failure Patients Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective is to evaluate whether RST serves as a useful indicator for early detection of heart failure exacerbation in the disease management of heart failure patients. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients diagnosed with heart failure according to the Heart Failure Management Guidelines (JCS/JHFS 2025) 2) Patients with a serum NT-proBNP level of 300 pg/mL or higher at the time of consent acquisition 3) Patients for whom written consent for study participation has been obtained from the patient or a legal representative 4) Patients aged 20 years or older Key exclusion criteria - 1) Patients whose bed or futon may be used for sleeping by individuals other than the study subject or by pets 2) Patients who, due to lifestyle factors, cannot undergo regular respiratory monitoring for at least 2 hours per night on 3 or more days per week 3) Patients without spontaneous breathing 4) Patients receiving treatment for chronic obstructive pulmonary disease (COPD) 5) Patients receiving assisted ventilation therapy such as Adaptive Servo-Ventilation (ASV) or Continuous Positive Airway Pressure (CPAP) therapy during sleep 6) Pregnant patients 7) Patients whose primary diagnosis is Obstructive Sleep Apnea Syndrome (OSAS) 8) Patients receiving guidance management using information from an implantable cardiac pacemaker or implantable cardioverter-defibrillator (ICD) 9) Patients with a history of cerebral hemorrhage or cerebral infarction, regardless of presence of sequelae 10) Patients undergoing dialysis therapy for renal failure or scheduled to start during the observation period 11) Patients currently participating in interventional studies (including clinical trials) 12) Patients for whom follow-up during the observation period is not feasible 13) Besides the above, patients deemed inappropriate by the physician Target Size - 90

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 11 Month 10 Day Date of IRB - 2025 Year 12 Month 18 Day Anticipated trial start date - 2026 Year 01 Month 16 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068834

Disclaimer: Curated by HT Syndication.