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Comparing Natriuretic Effects of ER Torsemide to IR Torsemide in Patients With Heart Failure

Description

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.

Conditions

Heart FailureEdemaPulmonary CongestionFluid Overload
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Related Conditions:

Heart FailureEdemaPulmonary CongestionFluid Overload

Study Overview

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Study Details

Study overview

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.

A Randomized, Two-Period, Two-Arm, Double-Dummy, Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide in Patients With Heart Failure (NEXT-HF)

Comparing Natriuretic Effects of ER Torsemide to IR Torsemide in Patients With Heart Failure

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Miami

Future Life Clinical Trials, Miami, Florida, United States, 33169

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age: 18 years or older.
  • * Informed Consent: Willing and able to sign the informed consent form.
  • * Stable Chronic HF: A clinical diagnosis of chronic heart failure considered stable by the patient's cardiologist/physician or another experienced clinician for at least one month prior to randomization.
  • * Current Diuretic Therapy: Receiving an oral dose of 20 mg to 80 mg daily of furosemide, or 10 mg to 40 mg daily dose of torsemide, or 1 mg to 4 mg daily dose of bumetanide, for about 30 days prior to randomization.
  • * Stable HF Medications: No anticipated changes in HF medications during the study period.
  • * Female Participants: Premenopausal women of childbearing potential must have a negative pregnancy test prior to study initiation and agree to use effective contraceptive methods throughout the study period.
  • * • Other Diuretics: Requirement for a diuretic other than furosemide, bumetanide, or torsemide (except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors) at randomization or during the study.
  • * Recent Cardiovascular Events: Myocardial infarction, stroke, transient ischemic attack, acute kidney injury, or acute HF requiring hospitalization within 30 days prior to randomization.
  • * Severe Lung Disease: Severe or symptomatic lung disease or respiratory symptoms distinct from HF.
  • * Urinary Issues: History of urinary incontinence, or inability to empty the bladder.
  • * Uncontrolled Comorbidities: Uncontrolled diabetes mellitus or hypertension.
  • * Renal Dysfunction: Estimated GFR \< 30 ml/min/1.72m².
  • * Cardiac Conditions: History of flash pulmonary edema or amyloid cardiomyopathy.
  • * Breastfeeding: Female participants who are breastfeeding.
  • * Recent Participation in Clinical Trials: Participation in another clinical trial within the last
  • * three months prior to randomization.
  • * Requirements for treatment with a non-steroidal anti-inflammatory drug (except for Aspirin up to 200 mg as PRN daily).
  • * Serum potassium concentration \<3.5 or \>5.5 mmol/L.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sarfez Pharmaceuticals, Inc.,

Salim Shah, PhD, JD, STUDY_CHAIR, Sarfez Pharmaceuticals, Inc.

Study Record Dates

2026-03-15