What is the mechanism of action of this treatment?

Loop diuretics, such as those being studied in the Furoscix trial, inhibit sodium and chloride reabsorption in the Loop of Henle, leading to increased urine production and reduced fluid overload. This is essential for heart failure patients as it decreases the volume of blood the heart must pump, reducing the heart's workload and alleviating symptoms like edema and shortness of breath. Other common treatments include ACE inhibitors, which lower blood pressure and reduce strain on the heart; beta-blockers, which slow the heart rate and decrease its demand for oxygen; and aldosterone antagonists, which prevent fluid retention and further reduce blood pressure. Together, these treatments help improve heart function and patient outcomes.

What side effects are associated with this type of intervention?

Loop diuretics, such as furosemide, commonly used in heart failure management, can cause side effects including electrolyte imbalances (e.g., hypokalemia, hyponatremia), dehydration, hypotension, and renal dysfunction. ACE inhibitors may lead to cough, hyperkalemia, and angioedema. Beta-blockers can cause bradycardia, fatigue, and worsening of heart failure symptoms initially. Aldosterone antagonists, like spironolactone, can result in hyperkalemia and, less commonly, gynecomastia in men.

What other types of research exist?

Promising alternatives to Furoscix for heart failure patients include SGLT2 inhibitors (e.g., dapagliflozin and empagliflozin), which have shown benefits in heart failure management beyond their glucose-lowering effects. Additionally, novel agents like vericiguat, a soluble guanylate cyclase stimulator, and omecamtiv mecarbil, a cardiac myosin activator, are emerging as effective treatments for heart failure. These therapies offer different mechanisms of action that can complement or provide alternatives to traditional loop diuretics.

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Loop Diuretic

Furoscix for Heart Failure (RESISTANCE-HF Trial)

Q: What prior FDA approvals exist?

The FDA has approved several loop diuretics for the treatment of heart failure, including furosemide, bumetanide, and torsemide. These medications work by inhibiting sodium and chloride reabsorption in the Loop of Henle, which increases urine production and helps reduce fluid overload. This mechanism is crucial in managing symptoms of heart failure, such as edema and shortness of breath.

Phase 2

Waitlist Available

Led By Ambarish Pandey, MD, MSCS

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

RESISTANCE-HF Trial Summary

This trial is testing whether the drug Furoscix is more effective than standard care at helping people with heart failure who retain fluid. This will be measured by urine sodium levels.

Who is the study for?

This trial is for English-speaking patients recently hospitalized for acute decompensated heart failure with specific blood markers, who can be screened within two weeks of hospital discharge and have a recent echocardiogram. It's not for those with severe kidney disease, very low blood pressure, recent ICU stay or inotrope use, pregnant women, certain other health conditions or treatments.Check my eligibility

What is being tested?

The study tests if Furoscix is better at removing excess fluid from the body compared to standard diuretic therapy in heart failure patients. Participants are split into groups by chance to receive either Furoscix or their usual care. The main measure of success is how much urine they produce after treatment.See study design

What are the potential side effects?

Potential side effects of Furoscix may include dehydration, electrolyte imbalances (like low potassium), low blood pressure, dizziness upon standing up quickly (orthostatic hypotension), and possible skin irritation where the medication is applied.

RESISTANCE-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-treatment diuretic efficiency as measured by cumulative urine output within 1 day.

Post-treatment diuretic efficiency as measured by spot urine sodium levels in 1 day

Secondary outcome measures

Number of participants with post-intervention need for emergency department visit or hospitalization

RESISTANCE-HF Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: > 11 BAN-ADHF, FuroscixExperimental Treatment1 Intervention

Patients with diuretic resistance as determined by a BAN-ADHF score > 11 will receive Furoscix over 5 hours at 8 mg/mL.

Group II: <= 11 BAN-ADHF, FuroscixExperimental Treatment1 Intervention

Patients without diuretic resistance as determined by BAN-ADHF score <= 11 will receive Furoscix over 5 hours at 8 mg/mL.

Group III: <= 11 BAN-ADHF, controlActive Control1 Intervention

Patients without diuretic resistance as determined by BAN-ADHF score <= 11 will receive home dose oral diuretic

Group IV: > 11 BAN-ADHF, controlActive Control1 Intervention

Patients with diuretic resistance as determined by a BAN-ADHF score > 11 will receive home dose oral diuretic.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Loop diuretics, such as those being studied in the Furoscix trial, inhibit sodium and chloride reabsorption in the Loop of Henle, leading to increased urine production and reduced fluid overload. This is essential for heart failure patients as it decreases the volume of blood the heart must pump, reducing the heart's workload and alleviating symptoms like edema and shortness of breath. Other common treatments include ACE inhibitors, which lower blood pressure and reduce strain on the heart; beta-blockers, which slow the heart rate and decrease its demand for oxygen; and aldosterone antagonists, which prevent fluid retention and further reduce blood pressure. Together, these treatments help improve heart function and patient outcomes.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,055 Previous Clinical Trials

1,054,799 Total Patients Enrolled

23 Trials studying Heart Failure

13,258 Patients Enrolled for Heart Failure

scPharmaceuticals, Inc.Industry Sponsor

11 Previous Clinical Trials

339 Total Patients Enrolled

9 Trials studying Heart Failure

282 Patients Enrolled for Heart Failure

Ambarish Pandey, MD, MSCSPrincipal InvestigatorUT Southwestern Medical Center

2 Previous Clinical Trials

140 Total Patients Enrolled

Media Library

Furoscix (Loop Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT05528588 — Phase 2

Heart Failure Research Study Groups: <= 11 BAN-ADHF, Furoscix, <= 11 BAN-ADHF, control, > 11 BAN-ADHF, control, > 11 BAN-ADHF, Furoscix

Heart Failure Clinical Trial 2023: Furoscix Highlights & Side Effects. Trial Name: NCT05528588 — Phase 2

Furoscix (Loop Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05528588 — Phase 2

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