Recruiting

Natriuresis-Guided Therapy

Sponsor:

Cardiology Research UBC

Code:

NCT07369856

Conditions

Heart Failure

Diuretics

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Natriuresis-Guided Up-Titration

Standard care

Natriuresis-Guided Down-Titration

Observational Follow-up

Study Details

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

Study ID

NCT07369856

Start date

Nov 4, 2025

Status verified date

Mar, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1 - Natriuresis-Guided Up-Titration

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.

other: Group 1 Standard of Care (Up-Titration Control)

Participants will receive usual clinical management of diuretics at the discretion of their treating physician without access to urine sodium-guided titration.

experimental: Group 2 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: Group 2 Standard Care (Down-Titration Control)

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

other: Group 3 Observational Cohort

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.

Interventions

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.

Standard care

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

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.

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.

Primary outcome measure

  • Change in Clinical Congestion Score (Group 1) [ Time Frame: 90 Days ]
  • Successful Down-Titration of Loop Diuretics (Group 2) [ Time Frame: 90 Days ]

Central Contacts and Locations

Central contacts

Natalie Bloch, MD

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

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada

Contacts

Amitai Segev, MD

604-875-4111asegev@yahoo.com

Principal Investigator:

Nathaniel Hawkins, MD

More Information

Sponsor

Cardiology Research UBC

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • heart failure
  • diuretics
  • management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardiology Research UBC on 2026-03-27.