Heart failure is a chronic condition that causes congestion and frequent hospitalizations. Diuretic doses are usually adjusted based on clinical judgment without an objective measure of response. This study will test the feasibility of using point-of-care urine sodium measurements to guide up-titration or down-titration of loop diuretics in ambulatory patients with heart failure.
Participants will be assigned to one of three groups based on congestion status. Groups 1 and 2 will be randomized 1:1 to natriuresis-guided therapy or standard care. Group 3 will be observational. The 90-day pilot trial will evaluate feasibility, clinical outcomes, and usability of a urine sodium-guided titration strategy.
Age ≥18 years
Diagnosis of heart failure according to the Universal Definition
Use of loop diuretics
Residing in VCH or PHC regions
eGFR <20 mL/min/1.73m²
Renal replacement therapy
High-risk clinical status requiring hospitalization
Inability to consent or perform required urine sampling
Parallel
Natriuresis-Guided Up-Titration
BehavioralDiuretic dose and regimen will be increased based on post-diuretic urine sodium concentration measured by a point-of-care sensor. Insufficient natriuresis (\<80 mmol/L) will prompt dose escalation using a predefined algorithm.
Standard care
Other interventionParticipants will receive usual clinical management of loop diuretics at the discretion of the treating physician, without natriuresis-guided adjustment.
Natriuresis-Guided Down-Titration
BehavioralLoop diuretic doses will be reduced based on urine sodium levels. If urine sodium ≥80 mmol/L, the current dose will be maintained; if \<80 mmol/L, dose will be reduced according to a predefined algorithm. Re-titration criteria include symptomatic weight gain \>2 kg in one week.
Observational Follow-up
Other interventionParticipants who do not meet inclusion criteria for Groups 1 or 2 will undergo baseline urine sodium assessment and routine clinical follow-up. No study-directed titration will occur.
Change in Clinical Congestion Score (Group 1)
Change in clinical congestion score among Group 1 participants. Minimum Value: 1 Maximum Value: 22 A higher score indicates a worse outcome.
Successful Down-Titration of Loop Diuretics (Group 2)
Proportion of Group 2 participants who maintain a reduced loop diuretic dose without needing up-titration during follow-up.
Dyspnea Visual Analogue Scale (VAS) Area Under the Curve
Change in dyspnea over time measured using serial VAS assessments.
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score
Change in heart-failure related quality of life using the KCCQ-12. 12-item version. Minimum Value: 0 Maximum Value: 100 Outcome Meaning: A higher score indicates a better outcome.
Change in New York Heart Association Functional (NYHA) Functional Classification
Change in New York Heart Association functional classification. Minimum Value: 1 Maximum Value: 4 Outcome Meaning: A higher class indicates a worse outcome.
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90 Days
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