Diuretics, Heart Failure
Conditions
Keywords
heart failure, diuretics, management
Brief 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.
Detailed 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.
Interventions
BEHAVIORALNatriuresis-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.
OTHERStandard care
Participants will receive usual clinical management of loop diuretics at the discretion of the treating physician, without natriuresis-guided adjustment.
BEHAVIORALNatriuresis-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.
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.
Sponsors
Cardiology Research UBC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Congestion Score (Group 1) | 90 Days | 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) | 90 Days | Proportion of Group 2 participants who maintain a reduced loop diuretic dose without needing up-titration during follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea Visual Analogue Scale (VAS) Area Under the Curve | 90 Days | Change in dyspnea over time measured using serial VAS assessments. |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score | 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. |
| Change in New York Heart Association Functional (NYHA) Functional Classification | 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. |
| Signs of Volume Overload | Proportion of participants with clinical signs of volume overload. | 90 Days |
| Change in Body Weight | 90 Days | Change in Body weight |
| Loop Diuretic Use and Dose | Baseline, 30 days, 90 days | Loop Diuretic Use and Dose at different timepoints |
| Guideline-Directed Medical Therapy (GDMT) Use | 90 days | Guideline-Directed Medical Therapy (GDMT) Use |
| NT-proBNP Concentration | 90 days | NT-proBNP Concentration changes |
| Hemoconcentration | 90 days | Changes in hemoglobin and hematocrit. |
| Change in Creatinine and BUN | 90 days | Change in Creatinine and BUN |
| Worsening Renal Function | 90 days | Creatinine increase ≥100% from baseline. |
| Hypokalemia | 90 Days | Frequency of potassium \<3.5 mEq/L. |
| Urine Sodium ≥80 mmol/L (Group 1) | 90 Days | Proportion of follow-up urine samples ≥80 mmol/L. |
| Point-of-Care vs Laboratory Sodium Measurement Agreement | Baseline to 90 days | Correlation between point-of-care and laboratory urine sodium measurements. |
| System Usability Scale | 90 Days | Usability of the natriuresis-guided process. Minimum Value: 0 Maximum Value: 100 Outcome Meaning: A higher score indicates a better outcome. |
Countries
Canada
Contacts
CONTACTNatalie Bloch, MD
Outcome results
None listed