Urine-based algorithm to personalize diuretics for fluid relief in acute heart failure
Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure
NA · Wroclaw Medical University · NCT07099885
This will test whether a urine-composition algorithm can guide IV diuretics to help adults hospitalized with acute heart failure remove excess fluid more effectively.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wroclaw Medical University (other) |
| Locations | 2 sites (Wroclaw, Dolnosląskie and 1 other locations) |
| Trial ID | NCT07099885 on ClinicalTrials.gov |
What this trial studies
Ninety adults hospitalized for acute heart failure with clinical congestion will be randomized 1:1 to algorithm-guided versus usual care diuretic management. All participants receive IV furosemide with the initial dose set by the treating physician and a spot urine sample taken two hours after dosing to measure sodium and creatinine. A machine-learning tool uses those values to predict six-hour urine output and, in the algorithm arm, to guide the diuretic plan for the first 24 hours; the control arm receives physician-directed care without the tool. The approach focuses on early, personalized adjustment of loop diuretics to improve short-term decongestion outcomes during the hospitalization.
Who should consider this trial
Good fit: Adults admitted within 24 hours primarily for acute heart failure with signs of congestion, NT-proBNP >1500 pg/ml, and an anticipated need for diuretics for at least 48 hours.
Not a fit: Patients with end-stage kidney disease on dialysis, those who are hemodynamically unstable requiring inotropes, or those with active IV-treated infections are excluded and unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the algorithm could speed up fluid removal and shorten time to clinical decongestion for hospitalized patients with acute heart failure.
How similar studies have performed: Previous work using urine sodium–guided diuretic strategies has shown promise, but machine-learning urine-output prediction tools are relatively novel and less tested in randomized settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Wroclaw, Dolnosląskie and 1 other locations
- Wroclaw Medical University — Wroclaw, Dolnosląskie, Poland (RECRUITING)
- Wroclaw Medical University — Wroclaw, Lower Silesian Voivodeship, Poland (RECRUITING)
Study contacts
- Study coordinator: Jan Biegus, MD, PhD
- Email: jan.biegus@umw.edu.pl
- Phone: 71 736 42 05
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Heart Failure, Congestion, Venous, decongestion, diuretics, algorithm, acute heart failure