Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061438) titled 'In-hospital trajectory of muscle mass changes assessed with repeated ultrasonography in older patients with acute heart failure:
A single-center prospective cohort study' on May 2.
Study Type:
Observational
Primary Sponsor:
Institute - Sagamihara Kyodo Hospital
Condition:
Condition - Acute Heart Failure
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Low muscle mass is a poor prognostic factor in patients with heart failure, but no studies have captured changes in muscle mass. The purpose of this study is to clarify the temporal changes in lower limb muscle mass during hospitalization in patients aged 65 years or older who were hospitalized with acute heart failure, based on skeletal muscle ultrasound examinations at multiple time points.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) The patients who were admitted to hospital due to acute heart failure
2) The diagnosis of heart failure is based on the Framingham criteria
3) The patients older than 65 years old
4) The patients who can walk by themselves before admission (including the patients who can walk using a staff and so on)
Key exclusion criteria - 1) The patients discharged within 9 days
2) The patients with NT-proBNP < 300 pg/mL at admission
3) The patients with acute coronary syndrome
4) The patients with acute myocarditis, acute pericarditis, or acute infective endocarditis
5) The patients undergoing maintenance dialysis
6) The patients undergoing continuous hemodiafiltration
7) The patients with symptomatic aortic stenosis, mitral stenosis, or obstructive hypertrophic cardiomyopathy
8) The patients receiving high-dose intravenous inotropic agents
9) The patients with untreated life-threatening arrhythmias
10) The patients with circulatory support
11) The patients using invasive mechanical ventilation
12) The patients who died in the hospital
13) The patients who did not provide consent
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 16 Day
Date of IRB - 2026 Year 04 Month 21 Day
Anticipated trial start date - 2026 Year 08 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070214
Disclaimer: Curated by HT Syndication.
