300 Participants Needed

Natriuresis-Guided Diuretic Therapy for Heart Failure

(SAND-HF Trial)

NB
Overseen ByNatalie Bloch, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cardiology Research UBC
Must be taking: Loop diuretics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks better methods to adjust diuretic medication (water pills) for people with heart failure, aiming to reduce symptoms and avoid hospital visits. Researchers will examine how urine sodium levels can guide medication adjustments. Participants will join one of three groups: two groups will have their medication adjusted based on sodium levels using natriuresis-guided down-titration or up-titration, while the third group will be observed without changes. People with heart failure who use loop diuretics and live in specific regions may be suitable for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance heart failure management.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it does require that you are already using loop diuretics and have a stable dose of furosemide for at least one week or one month, depending on the group.

What prior data suggests that this natriuresis-guided diuretic therapy is safe for heart failure patients?

In a previous study, researchers examined the safety of adjusting diuretic doses based on urine sodium levels. For the method that increases diuretic doses, results showed a 64% increase in sodium removal from the body, indicating effective fluid removal. Researchers monitored possible side effects like low potassium levels, low blood pressure, and changes in kidney function, but specific data on their frequency was not provided.

The safety of decreasing diuretic doses remains unclear. Some experts believe more research is needed to fully understand the risks and benefits of reducing diuretic doses in people with heart failure.

Overall, these studies explore new ways to manage diuretic doses safely. Prospective trial participants should discuss any concerns with their doctor, especially regarding side effects like low blood pressure or changes in kidney function.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses natriuresis-guided therapy to personalize diuretic doses for heart failure patients. Unlike standard treatments that rely on fixed diuretic dosing, this approach adjusts doses based on urine sodium levels, aiming for a more tailored and potentially more effective management of fluid balance. This could lead to better symptom control and fewer side effects, offering a promising advancement over traditional methods. By using a point-of-care sensor to measure urine sodium, the trial introduces a new way to optimize treatment in real-time, which could revolutionize how diuretics are used for heart failure.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that using urine sodium levels to guide diuretic treatment in heart failure patients can be helpful. In this trial, participants in the Natriuresis-Guided Down-Titration group will have their medication reduced based on sodium levels, although studies have not found major differences in outcomes like weight loss or hospital stay compared to usual care. Meanwhile, participants in the Natriuresis-Guided Up-Titration group will have their medication increased using this method, which has shown promise. Specifically, studies found that patients had shorter hospital stays when their diuretic doses were increased based on sodium levels. Overall, this approach aims to better control fluid levels in heart failure, potentially improving patient outcomes.26789

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure who live in specific regions. Group 1 includes those with significant congestion or on stable furosemide for at least a week. Group 2 consists of patients with mild symptoms, no recent hospitalization, and stable on furosemide for a month. Group 3 will include the first 100 eligible patients not fitting into Groups 1 or 2.

Inclusion Criteria

I am currently taking water pills.
I am 18 years old or older.
I have been diagnosed with heart failure.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline urine sodium assessment and initial clinical evaluations

1 week
1 visit (in-person)

Treatment

Participants receive natriuresis-guided or standard care diuretic titration

90 days
Regular follow-up visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Natriuresis-Guided Down-Titration
  • Natriuresis-Guided Up-Titration

Trial Overview

The study tests if measuring urine sodium to adjust water pill doses (up-titration/down-titration) is feasible and effective compared to standard care in managing heart failure. Participants are divided into three groups: two undergoing natriuresis-guided therapy versus standard care, and one observational group.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Group 3 Observational CohortExperimental Treatment1 Intervention
Group II: Group 2 Standard Care (Down-Titration Control)Experimental Treatment1 Intervention
Group III: Group 2 Natriuresis-Guided Down-TitrationExperimental Treatment1 Intervention
Group IV: Group 1 Standard of Care (Up-Titration Control)Experimental Treatment1 Intervention
Group V: Group 1 - Natriuresis-Guided Up-TitrationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cardiology Research UBC

Lead Sponsor

Trials
16
Recruited
7,100+

Citations

Protocolized natriuresis-guided diuretic therapy in acute heart ...

No significant differences were observed in weight loss, length of hospital stay, heart failure rehospitalization, or all-cause mortality.

Spot Analysis of Natriuresis to Guide up- or Down-titration ...

Heart failure is commonly associated with sodium retention and congestion. Loop diuretics are used to relieve congestion but are typically ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37640861/

Natriuresis-guided diuretic therapy in acute heart failure

Natriuresis-guided diuretic therapy in acute heart failure: a pragmatic randomized trial ... outcomes, we conducted the pragmatic, open ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41166680/

Natriuresis-Guided Diuretic Therapy for Acute Heart Failure

Effective ... natriuresis-guided therapy with standard care in adults hospitalized with acute heart failure. Primary outcomes were natriuresis ...

Natriuresis‐guided therapy in acute heart failure: rationale ...

Serial assessment of spot urine sodium predicts effectiveness of decongestion and outcome in patients with acute heart failure. Eur J Heart Fail ...

Exploring safety of down‐titrating diuretics in heart failure ...

Our data emphasize the need to further investigate this practice and prospectively investigate the true risks and benefits of reducing loop diuretic therapy in ...

Down‐titrating diuretics in heart failure

Down-titrating diuretics in heart failure. This article relates to: Exploring safety of down-titrating diuretics in heart failure management.

Economic and Quality-of-Life Outcomes of Natriuretic ...

The clinical report from GUIDE-IT also reported more total hospitalizations for the biomarker-guided arm (350 vs. 277 for the usual-care arm), ...

Natriuresis‐guided therapy in acute heart failure - PMC - NIH

This study will test the hypothesis that natriuresis‐guided therapy in patients with acute HF improves natriuresis and clinical outcomes.