Ziekenhuis Oost-Limburg AV
Genk, Limburg, 3600, Belgium
NCT Number: NCT06278792
The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are:
* difference in natriuresis and diuresis * feasibility of the protocol.
Participants will be asked to gather two 24 h urine collections.
Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Genk, Limburg, 3600, Belgium
The EASY-HF study was a single-centre, randomized, open-label study comparing standard of care (SOC) diuretic management at the treating physician's discretion with a nurse-led natriuresis-guided protocol in patients with ADHF. A bedside sensor was used to measure the urinary sodium content.The primary endpoint was total natriuresis after 48 hours. Secondary endpoints included safety profile and user-friendliness of both the protocol and the point-of-care sensor.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nurse-led natriuresis-guided protocol based on a bedside urinary sodium result
Diuretic therapy at the discretion of the physician
Time frame: 48 hours
Total natriuresis after 48 hours (mmol)
Time frame: 48 hours
Total diuresis after 48 hours (ml)
Time frame: 24 hours
Total natriuresis (mmol) during the first and second 24 h
Time frame: 24 hours
Total diuresis during the first and second 24 h
Time frame: 48 hours
Congestion score of no more than trace edema (score < 2) after 48 hours of diuretic treatment. Minimum score 0 (decongested), maximum score 10 (severe congested)
Time frame: 48 hours
Dose of loop diuretics and other diuretic agents administered
Time frame: 180 days
Questionnaire for the nursing staff with regard to user-friendliness of device and diuretic protocol (1 (totally disagree) to 10 (completely agree))
Time frame: 48 hours
Body weight change
Time frame: 180 days
Heart failure rehospitalization during the first 180 after start of the study
Time frame: 180 days
All-cause mortality during the first 180 after start of the study
Time frame: 180 days
The time frame between hospital admission and discharge will be calculated
Time frame: 48 hours
systolic blood pressure below 85mmHg
Time frame: 3-day follow-up
Any abnormal laboratory parameters in the blood (electrolytes, renal function) during a 3 day follow-up will be reported
Ziekenhuis Oost-Limburg
Other
Acronym: EASY-HF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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