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

NCT07369856 | Recruiting DMC

• 1 other identifier: H25-01581
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Diuretics

Keywords

heart failure; diuretics; management

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (15)

• Dyspnea Visual Analogue Scale (VAS) Area Under the Curve

  90 Days

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

  90 Days

• Change in New York Heart Association Functional (NYHA) Functional Classification

  Baseline, 30 days, 90 days

• Signs of Volume Overload

  Proportion of participants with clinical signs of volume overload.

• Change in Body Weight

  90 Days

Study Arms (5)

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.

Behavioral: Natriuresis-Guided Up-Titration

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.

Other: Standard care

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.

Behavioral: Natriuresis-Guided Down-Titration

Group 2 Standard Care (Down-Titration Control)

OTHER

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

Other: Standard care

Group 3 Observational Cohort

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.

Other: Observational Follow-up

Interventions

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.

Group 1 - Natriuresis-Guided Up-Titration

Standard care OTHER

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

Group 1 Standard of Care (Up-Titration Control); Group 2 Standard Care (Down-Titration Control)

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.

Group 2 Natriuresis-Guided Down-Titration

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.

Group 3 Observational Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cardiology Research UBC: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Natalie Bloch, MD

CONTACT

604-875-4111; natalie.blochisenberg@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)