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

Cardiology Research UBC

Status: Enrolling

Conditions: Diuretics; Heart Failure

Treatments: Other: Observational Follow-up; Other: Standard care; Behavioral: Natriuresis-Guided Down-Titration; Behavioral: Natriuresis-Guided Up-Titration

Study type: Interventional

Funder types: Other

Identifiers

NCT07369856

H25-01581

Details and patient eligibility

About

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.

Full description

Heart failure is commonly associated with sodium retention and congestion. Loop diuretics are used to relieve congestion but are typically adjusted based on symptoms and clinical judgment. Spot urine sodium concentration is an objective measure of diuretic response that may help personalize treatment. A point-of-care urine sodium sensor provides rapid results and may support effective decongestion or safe reduction of diuretics when appropriate.

This prospective, two-center pilot study includes three clinical groups:

Group 1: Up-titration cohort Patients with clinical congestion or objective evidence of congestion. These participants will be randomized 1:1 to natriuresis-guided up-titration or standard care.

Group 2: Down-titration cohort Stable, euvolemic patients who may safely reduce diuretic therapy. These participants will be randomized 1:1 to natriuresis-guided down-titration or standard care.

Group 3: Observational cohort The first 100 screened patients who do not meet criteria for Groups 1 or 2. These participants will undergo baseline assessments and routine follow-up without intervention.

Urine sodium will be measured at baseline and follow-up visits. Randomized participants will have diuretic doses adjusted based on predefined algorithms. Standard care participants will receive usual clinical management.

The primary aim is to assess feasibility, including recruitment, retention, adherence to sampling procedures, and workflow implementation. Secondary analyses will describe clinical, laboratory, and symptom-based outcomes to inform development of a larger definitive trial.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Diagnosis of heart failure according to the Universal Definition
• Use of loop diuretics
• Residing in VCH or PHC regions

Group-specific inclusion:

Group 1: Congestion score ≥5 OR objective congestion; stable furosemide ≥1 week Group 2: NYHA I-II; congestion score <5; no recent HF hospitalization; stable furosemide ≥1 month Group 3: First 100 eligible patients not meeting criteria for Groups 1 or 2

Exclusion criteria

• eGFR <20 mL/min/1.73m²
• Renal replacement therapy
• High-risk clinical status requiring hospitalization
• Inability to consent or perform required urine sampling

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 5 patient groups

Group 1 - Natriuresis-Guided Up-Titration

Experimental group

Description:

Loop diuretic doses will be up-titrated based on post-diuretic urine sodium concentration measured using a point-of-care sensor. Insufficient natriuresis (\<80 mmol/L) will prompt dose escalation according to a predefined algorithm.

Treatment:

Behavioral: Natriuresis-Guided Up-Titration

Group 1 Standard of Care (Up-Titration Control)

Other group

Description:

Participants will receive usual clinical management of diuretics at the discretion of their treating physician without access to urine sodium-guided titration.

Treatment:

Other: Standard care

Group 2 Natriuresis-Guided Down-Titration

Experimental group

Description:

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.

Treatment:

Behavioral: Natriuresis-Guided Down-Titration

Group 2 Standard Care (Down-Titration Control)

Other group

Description:

Participants will receive usual care without urine sodium-guided adjustments.

Treatment:

Other: Standard care

Group 3 Observational Cohort

Other group

Description:

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.

Treatment:

Other: Observational Follow-up