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

NCT07099885 | Recruiting

• 1 other identifier: 226/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Acute Heart Failure (AHF); Congestion, Venous

Keywords

decongestion; diuretics; algorithm; acute heart failure

Outcome Measures

Primary Outcomes (1)

• Cumulative diuresis over 48 hours.

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

  48 hours

Secondary Outcomes (8)

• Cumulative diuresis during first 24h of the study.

  24 hours

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

  48 hours

• Cummulative natriuresis over 48 hours of the study.

  48 hours

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

  48 hours

• Weight change at 24 hours.

  24 hours

Study Arms (2)

Algorithm based decongestion

EXPERIMENTAL

The patient will receive first dose of intravenous loop diuretic determined per the attending physician. Two hours after diuretic administration, a urine sample will be collected to measure sodium and creatinine concentrations. Using these values, the 6-hour urine output will be estimated with the aid of the machine learning, urine output prediction tool. This estimated diuresis will guide the diuretic therapy plan for the first 24 hours using the adaptative furosemide dosing. On the second day, the procedure will be repeated.

Diagnostic Test: Algorithhm-based decongestion

Standard of care

ACTIVE COMPARATOR

Diagnostic Test: Standard of Care (SOC)

Interventions

Standard of Care (SOC) DIAGNOSTIC_TEST

Diuretic treatment per attending physician.

Standard of care

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).

Algorithm based decongestion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• End-stage kidney disease requiring renal replacement therapy
• Hemodynamic instability requiring inotropic support
• Active infection requiring intravenous antibiotic therapy

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (2)

Wroclaw Medical University

Wroclaw, Dolnosląskie, 50-556, Poland

RECRUITING

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

RECRUITING

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jan Biegus, MD, PhD

CONTACT

71 736 42 05; jan.biegus@umw.edu.pl

Gracjan Iwanek, MD

CONTACT

71 733 11 12; gracjan.iwanek@student.umw.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 1, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)