Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07099885

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Heart Failure (AHF) Cardiovascular Diseases Congestion, Venous Hyperemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wroclaw Medical University, Wroclaw, Dolnosląskie, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care (SOC)

Diagnostic Test

Diuretic treatment per attending physician.

Algorithhm-based decongestion

Diagnostic Test

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

Primary outcomes

  1. Cumulative diuresis over 48 hours.

    Time frame: 48 hours

    Total urine output during the 48-hour duration of the study.

Secondary outcomes

  1. Cumulative diuresis during first 24h of the study.

    Time frame: 24 hours

    The total urine output during the first 24 hours of the study.

  2. Cumulative diuresis on the second 24h of the study.

    Time frame: 48 hours

    The total urine output during the second 24 hours of the study.

  3. Cummulative natriuresis over 48 hours of the study.

    Time frame: 48 hours

    The total amount of sodium excreted in the urine during the 48-hour duration of the study.

  4. Diuresis calculated per dose of loop diuretic over 48 hours of the study.

    Time frame: 48 hours

    The volume of urine output relative to the total dose of loop diuretic administered during the study period.

  5. Weight change at 24 hours.

    Time frame: 24 hours

    The difference in body weight measured at 24 hours compared to baseline.

  6. Weight change at 48 hours.

    Time frame: 48 hours

    The difference in body weight measured at 48 hours compared to baseline.

  7. Total length of hospitalization.

    Time frame: Up to 60 days

    This refers to the total length of the hospital stay, measured in days, from admission to discharge.

  8. Percentage of patients accurately red-flagged.

    Time frame: 48 hours

    Patients with an estimated 6-hour urine output of less than 900 ml will be red-flagged. This outcome indicates the proportion of patients who were correctly identified (red-flagged) as poor diuretic responders.

Study contacts

Contact information is provided by the study sponsor or research team.

Gracjan Iwanek, MD

CONTACT

[email protected]

71 733 11 12 ext. 0048

Jan Biegus, MD, PhD

CONTACT

[email protected]

71 736 42 05 ext. 0048

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Acronym: SAFER-DHF

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 1, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.