An interventional study of Natriuresis-Guided Up-Titration and Standard care in Heart Failure and Diuretics, sponsored by Cardiology Research UBC. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Cardiology Research UBC · Not applicable, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 300 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Cardiology Research UBC is the lead sponsor of 18 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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.
Behavioral: Natriuresis-Guided Up-Titration
Participants will receive usual clinical management of diuretics at the discretion of their treating physician without access to urine sodium-guided titration.
Other: Standard care
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.
Behavioral: Natriuresis-Guided Down-Titration
Participants will receive usual care without urine sodium-guided adjustments.
Other: Standard care
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.
Other: Observational Follow-up
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.
Participants will receive usual clinical management of loop diuretics at the discretion of the treating physician, without natriuresis-guided adjustment.
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.
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.
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.
Time frame: 90 Days
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.
Time frame: 90 Days
Dyspnea Visual Analogue Scale (VAS) Area Under the Curve
Change in dyspnea over time measured using serial VAS assessments.
Time frame: 90 Days
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.
Time frame: 90 Days
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.
Time frame: Baseline, 30 days, 90 days
Signs of Volume Overload
90 Days
Time frame: Proportion of participants with clinical signs of volume overload.
Change in Body Weight
Change in Body weight
Time frame: 90 Days
Loop Diuretic Use and Dose
Loop Diuretic Use and Dose at different timepoints
Time frame: Baseline, 30 days, 90 days
Guideline-Directed Medical Therapy (GDMT) Use
Guideline-Directed Medical Therapy (GDMT) Use
Time frame: 90 days
NT-proBNP Concentration
NT-proBNP Concentration changes
Time frame: 90 days
Hemoconcentration
Changes in hemoglobin and hematocrit.
Time frame: 90 days
Change in Creatinine and BUN
Change in Creatinine and BUN
Time frame: 90 days
Worsening Renal Function
Creatinine increase ≥100% from baseline.
Time frame: 90 days
Hypokalemia
Frequency of potassium \<3.5 mEq/L.
Time frame: 90 Days
Urine Sodium ≥80 mmol/L (Group 1)
Proportion of follow-up urine samples ≥80 mmol/L.
Time frame: 90 Days
Point-of-Care vs Laboratory Sodium Measurement Agreement
Correlation between point-of-care and laboratory urine sodium measurements.
Time frame: Baseline to 90 days
System Usability Scale
Usability of the natriuresis-guided process. Minimum Value: 0 Maximum Value: 100 Outcome Meaning: A higher score indicates a better outcome.
Time frame: 90 Days
Plan to share: No — Pilot feasibility study; data not intended for reuse.
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