RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-05-28

Study Completion:2026-03-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06995144

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Chris Wilcox, MD, PhD

CONTACT

703-627-1934

wilcoxch@georgetown.edu

Principal Investigator

Salim Shah, PhD, JD

STUDY_CHAIR

Sarfez Pharmaceuticals, Inc.

Study Locations (Sites)

Future Life Clinical Trials

Miami, Florida, 33169

United States

Collaborators and Investigators

Sponsor: Sarfez Pharmaceuticals, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-28

Study Completion Date2026-03-15

Study Record Updates