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Trial registered on ANZCTR


Registration number
ACTRN12623000923662
Ethics application status
Approved
Date submitted
9/08/2023
Date registered
28/08/2023
Date last updated
19/11/2023
Date data sharing statement initially provided
28/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Urinary sodium in the management of acute heart failure
Scientific title
Urinary sodium (UNa) guided titration of diuretic therapy for expedited care of acute heart failure: A randomised controlled trial
Secondary ID [1] 309302 0
Nil known
Universal Trial Number (UTN)
Trial acronym
UNa-HF
Linked study record
Study ACTRN12621000950864 was a pilot study of 60 patients. After analysing the results of that study, we designed this large-scale study with some amendment to the previous protocol.

Health condition
Health condition(s) or problem(s) studied:
Heart failure
 329478 0
Condition category
Condition code
Cardiovascular 326417 326417 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Urinary sodium (UNa) will be obtained from acute heart failure (AHF) patients admitted to the hospital within 6 hours after the commencement of loop diuretic therapy and then twice a day to adjust the dose of intravenous diuretics. The efficacy of this approach in adjusting the dose of intravenous diuretic in AHF patients will be compared to current standard methods (weight change and net fluid balance).
- Ward staff will obtain the urinary samples from patients. Investigators (cardiologists) will adjust the dose of diuretic.
- There will be a timetable in each patient's chart about the timing of urine sample collection that should be completed by nursing staff and will be monitored by investigators of the study.
Intervention code [1] 325823 0
Treatment: Other
Comparator / control treatment
In the standard care arm, UNa tests will be taken within 6 hours after the commencement of loop diuretic and each IV bolus dose, however, the treating clinical team will be blinded to the UNa results. Adjustment of diuretics would be subject to the treating clinical team based on standard clinical assessment for signs of congestion and clinical observation such as weight change.
Control group
Active

Outcomes
Primary outcome [1] 334380 0
Change in the clinical congestion score at 72 hours.
we will measure the clinical congestion score at admission and at 72 hours using a clinical congestion score (based on the assessment of simple clinical parameters, including JVP, pulmonary rales, dyspnoea, ankle oedema and fatigue). Each parameter score from 0 to 3 with a maximum score of 18.
Timepoint [1] 334380 0
at 72 hours from the start of IV diuretics.
Secondary outcome [1] 420442 0
Weight change
- based on daily weight loss on digital scale, documented in patient's chart
Timepoint [1] 420442 0
daily during admission up to 72hours
Secondary outcome [2] 420443 0
Acute kidney injury
- based on daily blood test, creatinine>2 times from baseline or creatinine increased by at least 26.4 µmol/L or need for dialysis.
Timepoint [2] 420443 0
daily during admission up to 72hours
Secondary outcome [3] 420444 0
Diuretic adverse events (severe hypokalemia (k<3.0), severe hyperkalemia (k>6), sustained symptomatic arrhythmia requiring pharmacological or device intervention, symptomatic hypotension (systolic blood pressure < 90mmHg), which resolves following IV fluid.
All patients will have daily blood tests (it is a standard care for all AHF patients), patient's chart and blood results will br reviewed daily by treating team and investigators of the study.
Timepoint [3] 420444 0
daily during admission up to 72hours
Secondary outcome [4] 420445 0
Worsening heart failure requiring the use of intravenous inotropes and/or mechanical circulatory support
-based on evaluation by cardiologist
Timepoint [4] 420445 0
daily during admission up to 72hours
Secondary outcome [5] 420446 0
All-cause death
- based on patient's chart and follow up contacts
Timepoint [5] 420446 0
up to 2 years post index admission
Secondary outcome [6] 420448 0
unplanned re-hospitalisation
- based on patient's chart and follow up contacts
Timepoint [6] 420448 0
up to 2 years post index admission
Secondary outcome [7] 429021 0
length of hospital stay. data will be collected based on patient chart (date of admission and discharge).
Timepoint [7] 429021 0
Secondary outcome [8] 429022 0
length of hospital stay. data will be collected based on patient chart (date of admission and discharge).
Timepoint [8] 429022 0
during the index admission
Secondary outcome [9] 429023 0
Reduction in clinical congestion score at day 5. please refer to more explanation in step 4.
Timepoint [9] 429023 0
during the index admission
Secondary outcome [10] 429024 0
Reduction in clinical congestion score at day 5. please refer to more explanation in step 4.
Timepoint [10] 429024 0
at 5 days from the start of IV diuretics
Secondary outcome [11] 429025 0
Time in days from admission to cessation of IV diuretic therapy (number of days that patient required intravenous diuretic therapy for fluid overload during index admission. This will be up to the clinical team based on their clinical assessment.
Timepoint [11] 429025 0
at 5 days from the start of IV diuretics
Secondary outcome [12] 429026 0
Time in days from admission to cessation of IV diuretic therapy (number of days that patient required intravenous diuretic therapy for fluid overload during index admission. This will be up to the clinical team based on their clinical assessment.
Timepoint [12] 429026 0
during index admission

Eligibility
Key inclusion criteria
1. Age: greater than or equal to 18 years
2. admitted under cardiology team with primary diagnosis of AHF, requiring intravenous diuretic therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Hemodynamically unstable patients requiring inotropic or mechanical circulatory support
2. Severe kidney dysfunction
3. Patients on dialysis or anuric at presentation
4. Patients on high-dose oral diuretic before admission
5. Patients transferred from another hospital
6. Unable to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The analysis will be performed after monitoring and cleaning data gathered from all patients. All analyses will be performed using intent-to-treat principles. Analyses will be performed by an experienced statistician.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
389
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24478 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 40062 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 313495 0
Hospital
Name [1] 313495 0
Metro North Health, The Prince Charles Hospital (TPCH)
Country [1] 313495 0
Australia
Primary sponsor type
Hospital
Name
Metro North Health, The Prince Charles Hospital (TPCH)
Address
627 Rode Road, Chermside, QLD, 4032
Country
Australia
Secondary sponsor category [1] 315270 0
None
Name [1] 315270 0
Address [1] 315270 0
Country [1] 315270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312682 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 312682 0
627 Rode Road, Chermside, QLD, 4032
Ethics committee country [1] 312682 0
Australia
Date submitted for ethics approval [1] 312682 0
07/09/2022
Approval date [1] 312682 0
26/06/2023
Ethics approval number [1] 312682 0
89985

Summary
Brief summary
Urinary sodium (UNa) enables rapid assessment of the response to diuretic therapy. If inadequate, it allows for rapid escalation of the diuretic dose until adequate diuresis is achieved. Insufficient decongestive therapy in acute heart failure (AHF) is associated with poor outcomes. Hence, spot urinary sodium concentration (UNa) has been proposed as a tool to rapidly assess the response to decongestive therapy and to estimate future outcomes by the Heart Failure Association of the European Society of Cardiology in 2019 and incorporated in the 2021 European Society of Cardiology Guidelines for the diagnosis and treatment of AHF. This recommendation is entirely based on expert opinion, and the efficacy of this approach has not been tested in a randomised controlled trial (RCT). In this prospective RCT, we investigate the clinical utility of spot UNa measures in the treatment of patients with AHF, and its effect on the short-term and long-term clinical outcomes compared with the standard treatment.
Primary Aim is to determine if titrating intravenous loop diuretic dosing based on serial spot UNa samples (intervention arm) compared with diuretic dose titration based on the evolution of clinical signs and symptoms (standard care arm) leads to a shorter length of stay in patients hospitalised with AHF.
Secondary aims are to determine if Una-guided loop diuretic titration is associated with:
(1) Greater weight loss and decongestion at 72 hours.
(2) Less adverse effects during admission
(3) Improved all-cause mortality and unplanned readmissions at 30 days, 6 months, 12 months, and 2 years
(4) Better prediction of the risk of adverse events, death and readmissions compared with standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125550 0
A/Prof Isuru Ranasinghe
Address 125550 0
The Prince Charles Hospital, Cardiology department
627 Rode Road, Chermside, QLD, 4032
Country 125550 0
Australia
Phone 125550 0
+61 731395765
Fax 125550 0
Email 125550 0
isuru.ranasinghe@health.qld.gov.au
Contact person for public queries
Name 125551 0
Dr Maryam Khorramshahi Bayat
Address 125551 0
The Prince Charles Hospital, Cardiology department
627 Rode Road, Chermside, QLD, 4032
Country 125551 0
Australia
Phone 125551 0
+61 426950965
Fax 125551 0
Email 125551 0
maryam.khorramshahibayat@health.qld.gov.au
Contact person for scientific queries
Name 125552 0
Dr Maryam Khorramshahi Bayat
Address 125552 0
The Prince Charles Hospital, Cardiology department
627 Rode Road, Chermside, QLD, 4032
Country 125552 0
Australia
Phone 125552 0
+61 426950965
Fax 125552 0
Email 125552 0
maryam.khorramshahibayat@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.