Acute Heart Failure (AHF)SAFER-DHFNCT07099885
Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure
A study testing Algorithhm-based decongestion in people with Acute Heart Failure (AHF) and Congestion, Venous, run by Wroclaw Medical University at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Congestion, Venous
- What is being tested?
- Algorithhm-based decongestion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Aug 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- End-stage kidney disease requiring renal replacement therapy
- Hemodynamic instability requiring inotropic support
- Active infection requiring intravenous antibiotic therapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Wroclaw Medical University
Wroclaw, Dolnosląskie, 50-556
Jan Biegus, M.D., Ph.D., 71 736 42 05 ext. 0048, jan.biegus@umw.edu.pl
Gracjan Iwanek, M.D., 71 733 11 12 ext. 0048, gracjan.iwanek@student.umw.edu.pl
- Recruiting
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-556
About this study
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
- Being tested
- Standard of Care (SOC), Algorithhm-based decongestion
- Keywords
- decongestion, diuretics, algorithm, acute heart failure
- Medical subject headings
- Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Diagnostic test
Diuretic treatment per attending physician.
Algorithhm-based decongestionDiagnostic test
Patient will receive standarized furosemide dosing based on the result of the algorithm-estimated 6h urine output (profiles of diuretic response).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Algorithhm-based decongestion |
| Standard of care | Active comparator | Not described Receives: Diagnostic Test: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative diuresis over 48 hours.
Total urine output during the 48-hour duration of the study.
Measured: 48 hours
Secondary outcomes (8)
Cumulative diuresis during first 24h of the study.
The total urine output during the first 24 hours of the study.
Measured: 24 hours
Cumulative diuresis on the second 24h of the study.
The total urine output during the second 24 hours of the study.
Measured: 48 hours
Cummulative natriuresis over 48 hours of the study.
The total amount of sodium excreted in the urine during the 48-hour duration of the study.
Measured: 48 hours
Diuresis calculated per dose of loop diuretic over 48 hours of the study.
The volume of urine output relative to the total dose of loop diuretic administered during the study period.
Measured: 48 hours
Weight change at 24 hours.
The difference in body weight measured at 24 hours compared to baseline.
Measured: 24 hours
Weight change at 48 hours.
The difference in body weight measured at 48 hours compared to baseline.
Measured: 48 hours
Total length of hospitalization.
This refers to the total length of the hospital stay, measured in days, from admission to discharge.
Measured: Up to 60 days
Percentage of patients accurately red-flagged.
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Biegus, MD, PhD, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099885
- Sponsor's protocol ID
- 226/2025
- Acronym
- SAFER-DHF
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07099885
- Acronym / sponsor ID
- SAFER-DHF / 226/2025
- Conditions
- Acute Heart Failure (AHF), Congestion, Venous
- Keywords
- decongestion, diuretics, algorithm, acute heart failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Algorithm based decongestion | Experimental | Diagnostic Test: Algorithhm-based decongestionThe 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. |
| Standard of care | Active comparator | Diagnostic Test: Standard of Care (SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- End-stage kidney disease requiring renal replacement therapy
- Hemodynamic instability requiring inotropic support
- Active infection requiring intravenous antibiotic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care (SOC)Diuretic treatment per attending physician. | Diagnostic test | Standard of care |
| Algorithhm-based decongestionPatient will receive standarized furosemide dosing based on the result of the algorithm-estimated 6h urine output (profiles of diuretic response). | Diagnostic test | Algorithm based decongestion |
Primary outcome
Cumulative diuresis over 48 hours.
Time frame: 48 hours
Total urine output during the 48-hour duration of the study.
8 secondary outcomes
Cumulative diuresis during first 24h of the study.
Time frame: 24 hours
Cumulative diuresis on the second 24h of the study.
Time frame: 48 hours
Cummulative natriuresis over 48 hours of the study.
Time frame: 48 hours
Diuresis calculated per dose of loop diuretic over 48 hours of the study.
Time frame: 48 hours
Weight change at 24 hours.
Time frame: 24 hours
Weight change at 48 hours.
Time frame: 48 hours
Total length of hospitalization.
Time frame: Up to 60 days
Percentage of patients accurately red-flagged.
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithhm-based decongestion in people with Acute Heart Failure (AHF) and Congestion, Venous, run by Wroclaw Medical University at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Biegus, MD, PhD (71 736 42 05 ext. 0048, jan.biegus@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative diuresis over 48 hours. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.