Furosemide for Heart Failure

(US-DASH Trial)

Overseen By Andrew Lurie, DO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Lakeland Regional Health Systems, Inc.

Must be taking: Diuretics

Disqualifiers: ICU admission, Myocardial infarction, Anuria, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether higher doses of diuretics, specifically furosemide, can improve outcomes for people hospitalized with acute heart failure. The researchers aim to determine if targeting higher sodium levels in urine results in better fluid removal, fewer hospital visits, and shorter hospital stays. Participants will have their urine checked to adjust the diuretic dose. The trial seeks adults admitted to the hospital with heart failure symptoms such as swollen legs or fluid in the lungs. As a Phase 4 trial, this research helps clarify how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for this treatment?

Research has shown that furosemide, a strong water pill, is usually well-tolerated and often treats heart failure. It removes extra water and salt from the body, but this can sometimes lead to dehydration or a loss of important minerals. Some studies suggest that high doses might harm certain body systems.

The FDA has already approved the treatment for heart failure, indicating that its safety is well understood. Patients should generally be monitored closely to manage these possible side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for heart failure because they explore a new way to optimize diuretic therapy. Unlike the traditional approach, which adjusts dosages based on symptoms and clinical judgment, these experimental treatments focus on achieving specific urine sodium concentrations (50 mmol/L and 85 mmol/L). This method could potentially lead to more precise and effective management of fluid overload in heart failure patients, offering a personalized approach that tailors treatment to the body's response.

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

Research has shown that furosemide treats heart failure by prompting the body to remove excess fluid through increased urination. In this trial, participants will join different treatment arms to assess furosemide's effectiveness. Studies have found that higher sodium levels in urine after taking furosemide correlate with better outcomes, such as shorter hospital stays. For example, patients with urine sodium levels below 50 mmol/L often remain hospitalized longer than those with higher levels. Lower sodium levels also link to a higher risk of worsening heart failure and kidney issues. Overall, targeting higher urine sodium levels could improve health outcomes for heart failure patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Anas Bizanti, MD

Principal Investigator

Lakeland Regional Hospital

Andrew Lurie, DO

Principal Investigator

Lakeland Regional Hospital

Are You a Good Fit for This Trial?

This trial is for patients hospitalized with acute heart failure. Participants should be able to provide urine samples regularly and follow the diuretic treatment plan. Specific inclusion and exclusion criteria are not listed, but typically, participants would need to meet certain health standards.

Inclusion Criteria

I am 18 or older with worsening heart failure, admitted to Lakeland Regional Medical Center.

I have signs of fluid overload, like swollen legs, neck vein swelling, or fluid in my lungs.

Exclusion Criteria

I have been admitted to the ICU.

I have had a heart attack with specific EKG changes.

I use more than 3 liters per minute of oxygen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive diuretics with urine sodium levels assessed every 2-4 hours for the first 72 hours of admission. Diuretic doses are adjusted based on urine sodium concentration.

72 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for hospital readmissions and other outcomes up to 90 days after discharge.

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Furosemide

Trial Overview The study tests if adjusting diuretics based on urine sodium levels can improve outcomes in acute heart failure. It compares a strategy of increasing diuretics for higher urine sodium targets against standard care practices.

How Is the Trial Designed?

Group I: 85 mmol/L urine sodium Experimental Treatment 1 Intervention

Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L

Group II: 50 mmol/L urine sodium Experimental Treatment 1 Intervention

Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L

Group III: Control Active Control 1 Intervention

Traditional diuretic dosing adjustment per provider

Who Is Running the Clinical Trial?

Lakeland Regional Health Systems, Inc.

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8294841/

The value of urinary sodium assessment in acute heart failure This systematic review discusses the current sum of evidence regarding urinary sodium assessment to evaluate diuretic efficacy in AHF.

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.123.011105

The Multicenter ENACT-HF Study | Circulation: Heart Failure The number of patients with a urinary sodium concentration <50 mmol/L after 2 hours was 29 (11.8%) in the standard of care arm and 18 (12.6%) ...

3. mp.pl mp.pl/paim/issue/article/16083

The ratio of furosemide dosage to urinary sodium ... Serial assessment of spot urine sodium predicts effectiveness of decongestion and outcome in patients with acute heart failure. Eur J Heart ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0735109720301947

Diuretic Therapy for Patients With Heart Failure A post-diuretic spot urine sodium <50 to 70 mmol/l is associated with higher risk of worsening kidney function, worsening HF, and long-term ...

5. cardiologyres.org cardiologyres.org/index.php/Cardiologyres/article/view/1696/1649

Effect of Post-Loop Diuretic Urinary Sodium Level on ... In our study, we observe a trend of higher length of stay in patients with lower post-loop diuretic urinary sodium levels (< 50 mmol/L) (8.67 ± 4.14 vs. 6.03 ± ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499921/

Furosemide - StatPearls - NCBI Bookshelf A boxed warning suggests the cautious use of furosemide as it is a potent diuretic, which can predispose to excessive loss of water and electrolytes, resulting ...

7. ahajournals.org ahajournals.org/doi/10.1161/circheartfailure.108.821785

Loop Diuretics in Acute Decompensated Heart Failure Administration of IV furosemide to patients with ADHF typically results in a prompt diuretic effect (within 30 minutes) that peaks at 1.5 hours.

8. academic.oup.com academic.oup.com/eurheartj/article/45/Supplement_1/ehae666.3356/7838972

Torsemide versus furosemide in patients with heart failure There was no difference between torsemide and furosemide when it comes to all-cause and cardiovascular mortality, but torsemide showed better results in ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa1005419

Diuretic Strategies in Patients with Acute Decompensated ... High doses of loop diuretics may have harmful effects, including activation of the renin–angiotensin and sympathetic nervous systems, ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002914923009414

Comparative Effect of Loop Diuretic Prescription on ... The 6-month composite outcome risk was 21.4% for torsemide, 24.7% for furosemide, and 24.9% for bumetanide. Compared with furosemide, the 6- ...