Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062455) titled 'Dietitian-led Multicenter Prospective Registry of Malnutrition in Older Patients with Heart Failure' on Aug. 3.
Study Type:
Observational
Primary Sponsor:
Institute - Other
Condition:
Condition - Heart failure
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This multicenter prospective observational study aims to assess malnutrition at hospital admission and discharge, investigate the provision of nutritional therapy during hospitalization, and examine the associations of these factors with clinical outcomes among older patients with heart failure admitted to acute-care hospitals.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Age 65 years or older at hospital admission.
(2) Hospitalization for worsening heart failure accompanied by heart failure symptoms, such as dyspnea at rest or on mild exertion, and signs of congestion, such as peripheral edema, pulmonary crackles, or chest radiographic evidence of pulmonary congestion.
(3) New York Heart Association (NYHA) functional class II to IV.
(4) Natriuretic peptide levels measured from 48 hours before hospital admission to the time of eligibility assessment meeting either of the following thresholds: NT-proBNP of at least 300 pg/mL or BNP of at least 100 pg/mL. For patients with atrial fibrillation, the corresponding thresholds are NT-proBNP of at least 900 pg/mL or BNP of at least 300 pg/mL.
Key exclusion criteria - (1) Initiation of invasive mechanical ventilation within 48 hours after hospital admission.
(2) Admission for diagnostic evaluation or elective surgery.
(3) Maintenance dialysis before hospital admission.
(4) An expected hospital stay of less than 7 days.
(5) A decision to withhold life-sustaining treatment or provision of palliative care.
(6) Previous enrollment in this study.
(7) Unsuitability for participation in this study, as determined by the site principal investigator or a site investigator.
Target Size - 1200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 29 Day
Date of IRB - 2026 Year 07 Month 29 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2033 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071480
Disclaimer: Curated by HT Syndication.