Spot Analysis of Natriuresis to Guide up- or Down-titration of Diuretic Therapy in Ambulatory Patients With Chronic Heart Failure (SAND-HF)

Official Summary

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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 300 participants

Interventions

• BEHAVIORAL: Natriuresis-Guided Up-Titration — Diuretic 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.
• OTHER: Standard care — Participants will receive usual clinical management of loop diuretics at the discretion of the treating physician, without natriuresis-guided adjustment.
• BEHAVIORAL: Natriuresis-Guided Down-Titration — Loop 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.
• OTHER: Observational Follow-up — Participants 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.

Primary Outcomes

• Change in Clinical Congestion Score (Group 1) (90 Days)
• Successful Down-Titration of Loop Diuretics (Group 2) (90 Days)

Secondary Outcomes

• Dyspnea Visual Analogue Scale (VAS) Area Under the Curve (90 Days)
• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score (90 Days)
• Change in New York Heart Association Functional (NYHA) Functional Classification (Baseline, 30 days, 90 days)
• Signs of Volume Overload (Proportion of participants with clinical signs of volume overload.)
• Change in Body Weight (90 Days)

Trial Locations

• Vancouver General Hospital, Vancouver, British Columbia, Canada

More Heart Failure Trials

View all Heart Failure clinical trials