Ireland
--:--IST
Recruiting Not applicable

Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure

NCT07099885 · tracked via the Priya Life Science Poland tracker
Phase
Not applicable
Started
2025-08-01
Last updated
2025-08-12

Condition(s) studied

Acute Heart Failure (AHF)Congestion, Venous

Investigational drug(s) / intervention(s)

Standard of Care (SOC)Algorithhm-based decongestion

Standard of Care (SOC): Diuretic treatment per attending physician.

Algorithhm-based decongestion: Patient will receive standarized furosemide dosing based on the result of the algorithm-estimated 6h urine output (profiles of diuretic response).

Study summary

The aim of this study is to evaluate the effectiveness of loop diuretic adaptative algorithm that is based on machine learning, urine output prediction tool, in decongestion of acute heart failure patients.

A total of 90 patients will be enrolled in the study. Of these, 45 will be assigned to the algorithm-based intervention group, while the remaining 45 will serve as the control group. In the control group, all decisions regarding diuretic therapy will be made solely by the attending physician, without the use of the algorithm.

Patients will receive intravenous furosemide, with the initial dose determined by the attending physician. Two hours after administration of the diuretic, a spot urine sample will be collected to measure sodium and creatinine concentrations. Based on these values, the 6-hour urine output will be estimated using the machine learning, urine output prediction tool (http://diuresis.umw.edu.pl). This estimate will guide the diuretic therapy plan for the first 24 hours of hospitalization. On the second day, the procedure will be repeated using the same methodology.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients over 18 years of age who provide informed consent * Ability to enroll in the study within the first 24 hours of hospitalization * Primary reason for hospitalization is acute heart failure with signs of congestion (at least moderate lower extremity edema) * NT-proBNP \> 1500 pg/ml * Anticipated need for diuretic therapy for at least 48 hours from the time of study enrollment Exclusion Criteria: * End-stage kidney disease requiring renal replacement therapy * Hemodynamic instability requiring inotropic support * Active infection requiring intravenous antibiotic therapy

Primary outcome measure(s)

  • Cumulative diuresis over 48 hours. — 48 hours
    Total urine output during the 48-hour duration of the study.

Trial sites (2)

FacilityCityRegionStatus
Wroclaw Medical University Wroclaw Dolnosląskie Recruiting
Wroclaw Medical University Wroclaw Lower Silesian Voivodeship Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07099885 on ClinicalTrials.gov ↗ ← All trials in Poland