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

NCT07369856 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-03-27

No results posted yet for this study

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

Interventions

BEHAVIORAL

Natriuresis-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.

OTHER

Standard care

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

BEHAVIORAL

Natriuresis-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.

OTHER

Observational Follow-up

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 & Collaborators

  • Cardiology Research UBC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-04
Primary Completion
2027-05-31
Completion
2027-12-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369856 on ClinicalTrials.gov