Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Natriuresis-Guided Up-Titration | Experimental | 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. |
|
| Group 1 Standard of Care (Up-Titration Control) | Other | Participants will receive usual clinical management of diuretics at the discretion of their treating physician without access to urine sodium-guided titration. |
|
| Group 2 Natriuresis-Guided Down-Titration | Experimental | 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. |
|
| Group 2 Standard Care (Down-Titration Control) | Other | Participants will receive usual care without urine sodium-guided adjustments. |
|
| Group 3 Observational Cohort | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea Visual Analogue Scale (VAS) Area Under the Curve | Change in dyspnea over time measured using serial VAS assessments. | 90 Days |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie Bloch, MD | Contact | 604-875-4111 | 66065 | natalie.blochisenberg@vch.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | Canada |
Pilot feasibility study; data not intended for reuse.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
|
| 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. |
|
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.
| 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. | Baseline, 30 days, 90 days |
| Signs of Volume Overload | 90 Days | Proportion of participants with clinical signs of volume overload. |
| Change in Body Weight | Change in Body weight | 90 Days |
| Loop Diuretic Use and Dose | Loop Diuretic Use and Dose at different timepoints | Baseline, 30 days, 90 days |
| Guideline-Directed Medical Therapy (GDMT) Use | Guideline-Directed Medical Therapy (GDMT) Use | 90 days |
| NT-proBNP Concentration | NT-proBNP Concentration changes | 90 days |
| Hemoconcentration | Changes in hemoglobin and hematocrit. | 90 days |
| Change in Creatinine and BUN | Change in Creatinine and BUN | 90 days |
| Worsening Renal Function | Creatinine increase ≥100% from baseline. | 90 days |
| Hypokalemia | Frequency of potassium <3.5 mEq/L. | 90 Days |
| Urine Sodium ≥80 mmol/L (Group 1) | Proportion of follow-up urine samples ≥80 mmol/L. | 90 Days |
| Point-of-Care vs Laboratory Sodium Measurement Agreement | Correlation between point-of-care and laboratory urine sodium measurements. | 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. | 90 Days |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided