Heart FailureSAND-HFNCT07369856
Spot Analysis of Natriuresis to Guide up- or Down-titration of Diuretic Therapy in Ambulatory Patients With Chronic Heart Failure
A study testing Natriuresis-Guided Up-Titration, Natriuresis-Guided Down-Titration and Observational Follow-up in people with Heart Failure and Diuretics, run by Cardiology Research UBC at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diuretics
- What is being tested?
- Natriuresis-Guided Up-Titration, Natriuresis-Guided Down-Titration and Observational Follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 4 Nov 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- eGFR <20 mL/min/1.73m²
- Renal replacement therapy
- High-risk clinical status requiring hospitalization
- Inability to consent or perform required urine sampling
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
Amitai Segev, MD, 604-875-4111 ext. 66065, asegev@yahoo.com
Nathaniel Hawkins, MD
About this study
Official title: Spot Analysis of Natriuresis to Guide up- or Down-titration of Diuretic Therapy in Ambulatory Patients With Chronic Heart Failure (SAND-HF)
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.
Read the detailed description
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.
- Conditions
- Heart Failure, Diuretics
- Being tested
- Natriuresis-Guided Up-Titration, Standard care, Natriuresis-Guided Down-Titration, Observational Follow-up
- Keywords
- heart failure, diuretics, management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natriuresis-Guided Up-TitrationBehavioural
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 careOther
Participants will receive usual clinical management of loop diuretics at the discretion of the treating physician, without natriuresis-guided adjustment.
Natriuresis-Guided Down-TitrationBehavioural
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-upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Natriuresis-Guided Down-Titration |
| Group 2 Standard Care (Down-Titration Control) | Other | Participants will receive usual care without urine sodium-guided adjustments. Receives: 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. Receives: Other: Observational Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 Days
Secondary outcomes (15)
Dyspnea Visual Analogue Scale (VAS) Area Under the Curve
Change in dyspnea over time measured using serial VAS assessments.
Measured: 90 Days
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score
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.
Measured: 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.
Measured: Baseline, 30 days, 90 days
Signs of Volume Overload
90 Days
Measured: Proportion of participants with clinical signs of volume overload.
Change in Body Weight
Change in Body weight
Measured: 90 Days
Loop Diuretic Use and Dose
Loop Diuretic Use and Dose at different timepoints
Measured: Baseline, 30 days, 90 days
Guideline-Directed Medical Therapy (GDMT) Use
Guideline-Directed Medical Therapy (GDMT) Use
Measured: 90 days
NT-proBNP Concentration
NT-proBNP Concentration changes
Measured: 90 days
Hemoconcentration
Changes in hemoglobin and hematocrit.
Measured: 90 days
Change in Creatinine and BUN
Change in Creatinine and BUN
Measured: 90 days
Worsening Renal Function
Creatinine increase ≥100% from baseline.
Measured: 90 days
Hypokalemia
Frequency of potassium <3.5 mEq/L.
Measured: 90 Days
Urine Sodium ≥80 mmol/L (Group 1)
Proportion of follow-up urine samples ≥80 mmol/L.
Measured: 90 Days
Point-of-Care vs Laboratory Sodium Measurement Agreement
Correlation between point-of-care and laboratory urine sodium measurements.
Measured: 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.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start4 Nov 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiology Research UBC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathaniel Hawkins, Cardiology Research UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369856
- Sponsor's protocol ID
- H25-01581
- Acronym
- SAND-HF
- Status last verified
- Mar 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot feasibility study; data not intended for reuse.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spot Analysis of Natriuresis to Guide up- or Down-titration of Diuretic Therapy in Ambulatory Patients With Chronic Heart Failure (SAND-HF)
- ClinicalTrials.gov ID
- NCT07369856
- Acronym / sponsor ID
- SAND-HF / H25-01581
- Conditions
- Heart Failure, Diuretics
- Keywords
- heart failure, diuretics, management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cardiology Research UBCUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Natriuresis-Guided Up-Titration | Experimental | Behavioral: Natriuresis-Guided Up-TitrationLoop 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 | Other: Standard careParticipants 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 | Behavioral: Natriuresis-Guided Down-TitrationLoop 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 | Other: Standard careParticipants will receive usual care without urine sodium-guided adjustments. |
| Group 3 Observational Cohort | Other | Other: Observational Follow-upParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- eGFR <20 mL/min/1.73m²
- Renal replacement therapy
- High-risk clinical status requiring hospitalization
- Inability to consent or perform required urine sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natriuresis-Guided Up-TitrationDiuretic 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. | Behavioural | Group 1 - Natriuresis-Guided Up-Titration |
| Standard careParticipants will receive usual clinical management of loop diuretics at the discretion of the treating physician, without natriuresis-guided adjustment. | Other | Group 1 Standard of Care (Up-Titration Control), Group 2 Standard Care (Down-Titration Control) |
| Natriuresis-Guided Down-TitrationLoop 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. | Behavioural | Group 2 Natriuresis-Guided Down-Titration |
| Observational Follow-upParticipants 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 | Group 3 Observational Cohort |
Primary outcome
Change in Clinical Congestion Score (Group 1)
Time frame: 90 Days
Change in clinical congestion score among Group 1 participants. Minimum Value: 1 Maximum Value: 22 A higher score indicates a worse outcome.
Successful Down-Titration of Loop Diuretics (Group 2)
Time frame: 90 Days
Proportion of Group 2 participants who maintain a reduced loop diuretic dose without needing up-titration during follow-up.
15 secondary outcomes
Dyspnea Visual Analogue Scale (VAS) Area Under the Curve
Time frame: 90 Days
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Score
Time frame: 90 Days
Change in New York Heart Association Functional (NYHA) Functional Classification
Time frame: Baseline, 30 days, 90 days
Signs of Volume Overload
Time frame: Proportion of participants with clinical signs of volume overload.
Change in Body Weight
Time frame: 90 Days
Loop Diuretic Use and Dose
Time frame: Baseline, 30 days, 90 days
Guideline-Directed Medical Therapy (GDMT) Use
Time frame: 90 days
NT-proBNP Concentration
Time frame: 90 days
Hemoconcentration
Time frame: 90 days
Change in Creatinine and BUN
Time frame: 90 days
Worsening Renal Function
Time frame: 90 days
Hypokalemia
Time frame: 90 Days
Urine Sodium ≥80 mmol/L (Group 1)
Time frame: 90 Days
Point-of-Care vs Laboratory Sodium Measurement Agreement
Time frame: Baseline to 90 days
System Usability Scale
Time frame: 90 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. Pilot feasibility study; data not intended for reuse.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natriuresis-Guided Up-Titration, Natriuresis-Guided Down-Titration and Observational Follow-up in people with Heart Failure and Diuretics, run by Cardiology Research UBC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie Bloch, MD (604-875-4111 ext. 66065, natalie.blochisenberg@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Congestion Score (Group 1) (time frame: 90 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.