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NCT Number: NCT07369856

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Diuretics Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location status: Recruiting

Location contact

Amitai Segev, MD

CONTACT

[email protected]

604-875-4111 ext. 66065

Amitai Segev, MD

SUB_INVESTIGATOR

Nathaniel Hawkins, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Natriuresis-Guided Up-Titration

Behavioral

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.

Standard care

Other

Participants will receive usual clinical management of loop diuretics at the discretion of the treating physician, without natriuresis-guided adjustment.

Natriuresis-Guided Down-Titration

Behavioral

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.

Observational Follow-up

Other

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

  1. Change in Clinical Congestion Score (Group 1)

    Time frame: 90 Days

    Change in clinical congestion score among Group 1 participants. Minimum Value: 1 Maximum Value: 22 A higher score indicates a worse outcome.

  2. Successful Down-Titration of Loop Diuretics (Group 2)

    Time frame: 90 Days

    Proportion of Group 2 participants who maintain a reduced loop diuretic dose without needing up-titration during follow-up.

Secondary outcomes

  1. Dyspnea Visual Analogue Scale (VAS) Area Under the Curve

    Time frame: 90 Days

    Change in dyspnea over time measured using serial VAS assessments.

  2. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score

    Time frame: 90 Days

    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.

  3. Change in New York Heart Association Functional (NYHA) Functional Classification

    Time frame: Baseline, 30 days, 90 days

    Change in New York Heart Association functional classification. Minimum Value: 1 Maximum Value: 4 Outcome Meaning: A higher class indicates a worse outcome.

  4. Signs of Volume Overload

    Time frame: Proportion of participants with clinical signs of volume overload.

    90 Days

  5. Change in Body Weight

    Time frame: 90 Days

    Change in Body weight

  6. Loop Diuretic Use and Dose

    Time frame: Baseline, 30 days, 90 days

    Loop Diuretic Use and Dose at different timepoints

  7. Guideline-Directed Medical Therapy (GDMT) Use

    Time frame: 90 days

    Guideline-Directed Medical Therapy (GDMT) Use

  8. NT-proBNP Concentration

    Time frame: 90 days

    NT-proBNP Concentration changes

  9. Hemoconcentration

    Time frame: 90 days

    Changes in hemoglobin and hematocrit.

  10. Change in Creatinine and BUN

    Time frame: 90 days

    Change in Creatinine and BUN

  11. Worsening Renal Function

    Time frame: 90 days

    Creatinine increase ≥100% from baseline.

  12. Hypokalemia

    Time frame: 90 Days

    Frequency of potassium <3.5 mEq/L.

  13. Urine Sodium ≥80 mmol/L (Group 1)

    Time frame: 90 Days

    Proportion of follow-up urine samples ≥80 mmol/L.

  14. Point-of-Care vs Laboratory Sodium Measurement Agreement

    Time frame: Baseline to 90 days

    Correlation between point-of-care and laboratory urine sodium measurements.

  15. System Usability Scale

    Time frame: 90 Days

    Usability of the natriuresis-guided process. Minimum Value: 0 Maximum Value: 100 Outcome Meaning: A higher score indicates a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Natalie Bloch, MD

CONTACT

[email protected]

604-875-4111 ext. 66065

Sponsors and collaborators

Lead sponsor

Cardiology Research UBC

Other

Registry information

Official study title

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

Acronym: SAND-HF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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