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Urinary sodium in the management of acute heart failure - Trial ANZCTR12623000923662

Access comprehensive clinical trial information for ANZCTR12623000923662 through Pure Global AI's free database. This Not Applicable trial is sponsored by Metro North Health, The Prince Charles Hospital (TPCH) and is currently Not yet recruiting. The study focuses on Heart failure.

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ANZCTR12623000923662
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Trial Details
Australian New Zealand Clinical Trials Registry โ€ข ANZCTR12623000923662
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Urinary sodium in the management of acute heart failure
Urinary sodium (UNa) guided titration of diuretic therapy for expedited care of acute heart failure: A randomised controlled trial

Study Focus

Heart failure

Interventional

other

Sponsor & Location

Metro North Health, The Prince Charles Hospital (TPCH)

Australia

Timeline & Enrollment

Not Applicable

Sep 01, 2023

Dec 31, 2025

Primary Outcome

Length of hospital stay -number of days admitted, based on patient's chart

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.

ICD-10 Classifications

Heart failure
Heart failure, unspecified
Congestive heart failure
Hypertensive heart disease with (congestive) heart failure
Left ventricular failure

Data Source

Australian New Zealand Clinical Trials Registry

ANZCTR12623000923662

Non-Device Trial