Extended vs Immediate Release Torsemide for Heart Failure

(NEXT-HF Trial)

Overseen By Chris Wilcox, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Sarfez Pharmaceuticals, Inc.

Must be taking: Loop diuretics

Must not be taking: Other diuretics

Disqualifiers: Recent cardiovascular events, severe lung disease, uncontrolled diabetes, 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: 4

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to learn whether a morning dose of extended-release torsemide enhances renal sodium excretion after lunch (4-8 hours after dosing) compared to immediate-release torsemide. This is a randomized, double-blind, crossover study in patients with heart failure who are on a stable dose of a loop diuretic. During the study period, participants' current loop diuretics will be replaced with an equivalent dose of either immediate-release or extended-release torsemide. Following a one-week stabilization period on the assigned torsemide formulation, patients will report to the clinical site for an assessment visit. On the study day, patients will take a single dose of the same torsemide formulation they have been on for the past week, administered after breakfast. Urine samples be collected are: * 0-4 hours post-dosing (pre-lunch period) * 4-8 hours post-dosing (post-lunch period) * 8-24 hours post-dosing (24 hours period) The primary endpoint will be urinary sodium excretion (4-8 hours after dosing). This will be compared between the extended-release arm and the immediate-release arm to assess the efficacy of prolonged diuretic action. In addition, urinary potassium and creatinine excretion and creatinine clearance will be measured in all urine samples as the safety endpoints.

Research Team

Salim Shah, PhD, JD

Principal Investigator

Sarfez Pharmaceuticals, Inc.

Eligibility Criteria

This trial is for heart failure patients who are already taking loop diuretics. They should be stable on their current medication and willing to switch to either extended-release or immediate-release Torsemide for the study. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

My heart failure medications will not change during the study.

I am 18 years old or older.

Informed Consent: Willing and able to sign the informed consent form

Exclusion Criteria

I am not taking any NSAIDs except for possibly low-dose Aspirin.

Breastfeeding: Female participants who are breastfeeding

I do not have uncontrolled diabetes or high blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Stabilization

Participants are stabilized on the assigned torsemide formulation

1 week

1 visit (in-person)

Treatment Period 1

Participants receive either IR or ER torsemide for 6-10 days, followed by a test day with urine and blood sample collection

6-10 days

1 visit (in-person)

Washout/Crossover

Participants switch to the alternate torsemide formulation for 6-10 days, followed by a test day with urine and blood sample collection

6-10 days

1 visit (in-person)

Follow-up

Participants resume their pre-enrollment diuretic regimen and continue routine follow-up with their physicians

Treatment Details

Interventions

• Torsemide

Trial Overview The study compares two forms of Torsemide: an extended-release version that's supposed to work over a longer period, and an immediate-release version that works quickly. It's a randomized, double-blind crossover trial where participants will try both versions at different times.

Participant Groups

Group I: Arm 1 IR torsemide Active Control 2 Interventions

Approximately half of the participants will receive 20 mg IR torsemide followed by 24 mg ER torsemide or 40mg IR torsemide followed by 48 mg ER torsemide (6-10 days each)

Group II: ARM 2 ER torsemide Active Control 2 Interventions

The other half will receive 24 mg ER torsemide followed by 20 mg IR torsemide, or 48 mg ER torsemide followed by 40 mg IR torsemide (6-10 days each)

Who Is Running the Clinical Trial?

Sarfez Pharmaceuticals, Inc.

Lead Sponsor

Trials

6

Recruited

100+