Trial · NCT05411991
Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
NCT05411991, Phase 4, Completed, Vrije Universiteit Brussel; results first posted 2025-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment. Trials, record NCT05411991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05411991
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
- NCT number
- NCT05411991
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 107 participants, actual
- Lead sponsor
- Vrije Universiteit Brussel
- Conditions
- Acute Heart Failure, Diuretics Drug Reactions
- Interventions
UNa measurement after intravenous loop diuretic bolus, Intravenous acetazolamide 500 mg OD, Intravenous bumetanide TID, Oral chlorthalidone OD, Intravenous canrenoate 200 mg OD, Maintenance infusion, Oral potassium supplements, Intravenous hypertonic saline, Switch to oral diuretic therapy, Usual AHF care
- First posted
- 2022-06-09
- Last updated
- 2026-09-11
- Other registries' IDs
- eudract:2021-005426-18
- Results first posted
- 2025-08-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mortality, Days in Hospital & Decongestion | 30 days | The net treatment benefit is calculated for the hierarchical composite primary endpoint. Every patient from the intervention group is pair-wise compared with each patient from the control group to declare a winner or tie. The following criteria are sequentially assessed to declare a winner or a tie: 1. Any subject surviving until 30 days after randomization wins from a subject who died. If both subjects did not survive until day 30, there is a tie. 2. In a pair of subjects, both surviving up till day 30, the subject with the highest number of days alive and out of hospital or care facility during the 30-day follow-up window is declared the winner. 3. In a pair of subjects, both surviving up till day 30 with the same number of days alive and out of hospital/care facility, the subject with the greatest relative reduction in NTproBNP from baseline is the winner (rounded to the closest percentage with a minimal difference of 5%). If the difference is \<5%, there is a tie. |
| Secondary | Renal Safety Endpoint | 30 days | Number of patients with doubling of the serum creatinine or plasma cystatin C value compared to baseline with an absolute value \>2 mg/dL or \>2 mg/L, respectively, or the need for ultrafiltration and/or renal replacement therapy during the index hospital admission. |
| Secondary | Hemodynamic Safety Endpoint | 30 days | Number of patients with a ystolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg or need for vasopressors and/or inotropes during the index hospital admission. |
| Secondary | Natriuretic Peptide Change After 30 Days | 30 days | Relative NT-proBNP change from baseline to 30 days after randomisation \[%\]. |
| Secondary | Cancer Antigen 125 (CA125) Change After 30 Days | 30 days | Relative cancer antigen 125 (CA125) change from baseline to 30 days after randomisation \[%\]. |
| Secondary | Number of Participants With Successful Clinical Decongestion | 30 days | Number of participants with no more than trace edema, absence of jugular venous distension and no rales upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol. |
| Secondary | Length of Intravenous Diuretic Therapy | 30 days | Number of consecutive days from randomization during the index admission on which intravenous diuretic therapy was administered. |
| Secondary | Overall Well-being After Decongestion | 30 days | Five-point Likert scale for overall well-being upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol and compared with the moment of randomisation (5: much improved/4: slightly improved/3: neutral/2: slightly worse/1: much worse). |
| Secondary | Length of the Index Hospital Admission | 30 days | Length of the index hospital admission \[days\]. |
| Secondary | Number of Participants Who Are Death, or Have a Non-elective Hospital Admission or Non-elective Medical Contact | 30 days | Number of participants who are death, or have a non-elective hospital admission or non-elective medical contact |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mortality, Days in Hospital & Decongestion | 30 days | % wins | NUMBER | |
| SECONDARY | Renal Safety Endpoint | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hemodynamic Safety Endpoint | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Natriuretic Peptide Change After 30 Days | 30 days | This endpoint could not be assessed in patients who died (n=3 in the intervention arm and n=4 in the control arm). In addition, 1 patient in the intervention arm withdrew consent during follow-up. Vital status could be assessed, but no blood sample was available for this patient. Finally, 5 blood samples were missing in the control group because patients were unable to physically attend the final follow-up visit. | % of change from baseline | MEAN |
| SECONDARY | Cancer Antigen 125 (CA125) Change After 30 Days | 30 days | This endpoint could not be assessed in patients who died (n=3 in the intervention arm and n=4 in the control arm). In addition, 1 patient in the intervention arm withdrew consent during follow-up. Vital status could be assessed, but no blood sample was available for this patient. Finally, 5 blood samples were missing in the control group because patients were unable to physically attend the final follow-up visit. | % of change from baseline | MEAN |
| SECONDARY | Number of Participants With Successful Clinical Decongestion | 30 days | This endpoint was not be assessed in patients who died (n=3 in the intervention arm and n=4 in the control arm). One edema score was missing in the control group and could not be retrieved, precluding the assessment of decongestion success. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Length of Intravenous Diuretic Therapy | 30 days | This endpoint was not be assessed in patients who died (n=3 in the intervention arm and n=4 in the control arm). | days | MEDIAN |
| SECONDARY | Overall Well-being After Decongestion | 30 days | This endpoint could not be assessed in patients who died before switching to oral diuretics (n=1 in the intervention group and n=3 in the control group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Length of the Index Hospital Admission | 30 days | This endpoint was not be assessed in patients who died (n=3 in the intervention arm and n=4 in the control arm). | days | MEDIAN |
| SECONDARY | Number of Participants Who Are Death, or Have a Non-elective Hospital Admission or Non-elective Medical Contact | 30 days | One patient in the intervention arm withdrew consent during follow-up. Vital status could be assessed, but not data on hospitalizations or medical contacts. Therefore the overall number of participants analyzed is 1 lower than for the primary endpoint. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mortality, Days in Hospital & Decongestion | Intervention Arm | 54.68 | % wins | ||
| Mortality, Days in Hospital & Decongestion | Control Arm | 44.16 | % wins | ||
| Renal Safety Endpoint | Intervention Arm | 9 | Participants | ||
| Renal Safety Endpoint | Control Arm | 3 | Participants | ||
| Hemodynamic Safety Endpoint | Intervention Arm | 10 | Participants | ||
| Hemodynamic Safety Endpoint | Control Arm | 4 | Participants | ||
| Natriuretic Peptide Change After 30 Days | Intervention Arm | -37 | Standard Deviation 64 | % of change from baseline | |
| Natriuretic Peptide Change After 30 Days | Control Arm | -46 | Standard Deviation 40 | % of change from baseline | |
| Cancer Antigen 125 (CA125) Change After 30 Days | Intervention Arm | -69 | Standard Deviation 40 | % of change from baseline | |
| Cancer Antigen 125 (CA125) Change After 30 Days | Control Arm | -21 | Standard Deviation 68 | % of change from baseline |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention Arm | 53 | |
| Overall Study | STARTED | Control Arm | 54 | |
| Overall Study | COMPLETED | Intervention Arm | 52 | |
| Overall Study | COMPLETED | Control Arm | 51 | |
| Overall Study | NOT COMPLETED | Intervention Arm | 1 | |
| Overall Study | NOT COMPLETED | Control Arm | 3 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypokalaemia | Renal and urinary disorders | Intervention Arm | 13 | 52 | 13 |
| other | Hypokalaemia | Renal and urinary disorders | Control Arm | 21 | 51 | 21 |
| serious | Acute kidney injury | Renal and urinary disorders | Intervention Arm | 2 | 52 | 2 |
| serious | Acute kidney injury | Renal and urinary disorders | Control Arm | 3 | 51 | 3 |
| serious | Worsening heart failure | Cardiac disorders | Intervention Arm | 1 | 52 | 1 |
| serious | Worsening heart failure | Cardiac disorders | Control Arm | 7 | 51 | 7 |
| serious | Urgent electrical cardioversion of atrial fibrillation | Cardiac disorders | Intervention Arm | 1 | 52 | 1 |
| serious | Urgent electrical cardioversion of atrial fibrillation | Cardiac disorders | Control Arm | 1 | 51 | 1 |
| serious | Symptomatic bradycardia | Cardiac disorders | Intervention Arm | 0 | 52 | 0 |
| serious | Symptomatic bradycardia | Cardiac disorders | Control Arm | 1 | 51 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Arm | 3 | 52 |
| Total, all-cause mortality | Control Arm | 4 | 51 |
| Total, other adverse events | Intervention Arm | 13 | 52 |
| Total, other adverse events | Control Arm | 21 | 51 |
| Total, serious adverse events | Intervention Arm | 6 | 52 |
| Total, serious adverse events | Control Arm | 14 | 51 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention Arm vs Control Arm: Number of Participants Who Are Death, or Have a Non-elective Hospital Admission or Non-elective Medical Contact | Trial comparisons |
| Intervention Arm vs Control Arm: Hemodynamic Safety Endpoint | Trial comparisons |
| Intervention Arm vs Control Arm: Renal Safety Endpoint | Trial comparisons |
| Intervention Arm vs Control Arm: deaths from any cause | Trial comparisons |
| Intervention Arm vs Control Arm: Number of Participants With Successful Clinical Decongestion | Trial comparisons |
| Intervention Arm vs Control Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05411991
GET https://conductscience.org/api/trials/v1/NCT05411991/results?page=2