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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Vancouver General Hospital
RECRUITING
Vancouver
Contact Information
Primary
Natalie Bloch, MD
natalie.blochisenberg@vch.ca
604-875-4111
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 300
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Cardiology Research UBC

This content was sourced from clinicaltrials.gov