What side effects are associated with this type of intervention?

Loop diuretics, such as furosemide and torsemide, are commonly used in the treatment of heart failure to inhibit the sodium-potassium-chloride cotransporter in the loop of Henle. Known side effects of these medications include electrolyte imbalances (such as hypokalemia), dehydration, hypotension, and renal dysfunction. Torsemide may have a lower incidence of abnormal serum potassium levels and potentially lower mortality compared to furosemide. Both medications can also cause fluid retention issues and require careful monitoring of kidney function and electrolyte levels.

What prior FDA approvals exist?

The FDA has approved several loop diuretics for the treatment of heart failure, focusing on the inhibition of the sodium-potassium-chloride cotransporter in the loop of Henle. Furosemide and torsemide are two such drugs that are commonly used. Furosemide, one of the most widely prescribed loop diuretics, helps reduce fluid retention and swelling caused by heart failure. Torsemide, another loop diuretic, is often used as an alternative to furosemide and has a longer duration of action. Both drugs work by preventing the reabsorption of sodium and chloride in the kidneys, thereby increasing urine output and reducing fluid buildup in the body.

What other types of research exist?

Promising novel alternatives to Furosemide and Torsemide for heart failure patients include SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin), which have shown benefits in reducing heart failure hospitalizations and improving cardiovascular outcomes. Additionally, ARNI (angiotensin receptor-neprilysin inhibitors) like sacubitril/valsartan have demonstrated superior efficacy in reducing mortality and heart failure-related hospitalizations compared to traditional RAAS inhibitors. These alternatives offer different mechanisms of action and have been supported by recent clinical trials for their effectiveness in heart failure management.

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Loop Diuretic

Torsemide vs Furosemide for Heart Failure (TFO Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for heart failure include loop diuretics such as furosemide and torsemide, which work by inhibiting the sodium-potassium-chloride cotransporter in the loop of Henle. This inhibition leads to increased excretion of sodium, chloride, and water, reducing fluid overload and alleviating symptoms like edema and shortness of breath. Effective fluid management is crucial for heart failure patients as it helps to decrease the workload on the heart, improve cardiac function, and enhance overall quality of life.

Phase 3

Waitlist Available

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Plan for a daily outpatient oral loop diuretic regimen with anticipated need for long term loop diuretic use

≥ 18 years of age

Must not have

Implanted left ventricular assist device or implant anticipated <3 months

End-stage renal disease requiring dialysis therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests two different water pills, furosemide and torsemide, to see which is better for heart failure patients. It focuses on patients who are already taking these medications. The pills work by helping the body get rid of extra fluid through increased urine production. Torasemide has been developed as a newer type of water pill with a longer-lasting effect and better absorption compared to furosemide.

Who is the study for?

This trial is for adults over 18 with stable heart failure who've been on a steady dose of diuretics for at least a month. It's not for pregnant or nursing women, those planning to conceive, patients with end-stage kidney disease on dialysis, heart transplant recipients or candidates, individuals with life-limiting conditions, or anyone allergic to the study drugs.

What is being tested?

The trial aims to see which diuretic—Furosemide or Torsemide—is more effective in managing stable heart failure when taken orally as part of daily treatment. Participants will be randomly assigned one of these medications and monitored for outcomes.

What are the potential side effects?

Possible side effects from Furosemide and Torsemide include dehydration, electrolyte imbalances (like low potassium), low blood pressure, dizziness upon standing up quickly, kidney issues and gastrointestinal problems such as nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on a daily oral medication for swelling and expect to take it long-term.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or will soon get a heart pump implant.

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I am on dialysis for end-stage kidney disease.

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My life expectancy is less than 12 months due to my condition.

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I have had a heart transplant or am on the waiting list for one.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants All-cause Mortality, Measured at 1 Year.

Secondary study objectives

All-cause Hospitalization

Change in Weight

Total Hospitalizations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: FurosemideActive Control1 Intervention

Furosemide, oral, dosage and frequency determined by treating physician or provider. 1 mg torsemide to 2-4 mg oral furosemide

Group II: TorsemideActive Control1 Intervention

Torsemide, oral, dosage and frequency determined by treating physician or provider. 1 mg torsemide to 2-4 mg oral furosemide

0 / 6Eligibility criteria met

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

Common treatments for heart failure include loop diuretics such as furosemide and torsemide, which work by inhibiting the sodium-potassium-chloride cotransporter in the loop of Henle. This inhibition leads to increased excretion of sodium, chloride, and water, reducing fluid overload and alleviating symptoms like edema and shortness of breath. Effective fluid management is crucial for heart failure patients as it helps to decrease the workload on the heart, improve cardiac function, and enhance overall quality of life.

READY: relative efficacy of loop diuretics in patients with chronic systolic heart failure-a systematic review and network meta-analysis of randomised trials.