Clinical trial NCT06708611: A Crossover Study of Patients with HF to Compare Natriuretic Effects of IR Torsemide Vs. ER Torsemide Over 12 Hrs
Official title: A Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide Over 12 Hours After Dosing in Patients with Heart Failure (EXTOR-HF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Sarfez Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, double-dummy, two-period, two arm, randomized, crossover clinical trial.
Primary purpose: TREATMENT

Brief summary: This is a randomized double-blind crossover study of the patients with stable heart failure, who are taking a loop diuretic. During the study period, the participants' loop diuretics will be replaced by the equivalent dose of immediate release/extended release torsemide for one week. After a one week period, they will report to the site and will receive a single dose of either immediate release or extended release Torsemide. The sodium excretion will be measured for six hours after dosing and for an additional six hours after a high salt lunch.

Detailed description: The goal of this randomized double-blind crossover study is to assess whether extended release torsemide has a better efficacy than immediate release torsemide to induce renal sodium excretion after a salty lunch in patients with heart failure. The study will address if:

* the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a morning dose of extended release torsemide is different from the amounts after the immediate release torsemide.
* the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amounts after the immediate release torsemide.
* the amount of excreted sodium in the urine during the 24 hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amount after the immediate release torsemide.

Eligibility criteria: Inclusion Criteria:

* Man or woman over the age of 18 years.
* Willing and able to sign the informed consent.
* A clinical diagnosis of chronic HF that is considered by patient's cardiologist/physician or an experienced clinician to be stable over the one-month period prior to randomization.
* Receiving oral furosemide (or equivalent doses of torsemide or bumetanide) for about 30 days prior to randomization.
* No anticipated changes in HF medications during the study period.
* Premenopausal women of child-bearing potential have a negative pregnancy test prior to beginning of the study and agree to use effective contraceptive methods during the study period

Exclusion Criteria:

* Requirement for a diuretic other than furosemide, bumetanide or torsemide except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors, at randomization and during the study.
* Myocardial infarction, stroke, transient ischemic attack, acute kidney injury or acute HF requiring admission to hospital within the last 30 days prior to randomization.
* Severe / symptomatic lung disease or respiratory symptoms distinct from HF.
* Urinary incontinence or inability to empty bladder.
* Uncontrolled diabetes mellitus or uncontrolled hypertension.
* Estimated GFR \< 30 ml/min/1.72m2.
* History of flash pulmonary edema or amyloid cardiomyopathy.
* Female patients who are breastfeeding.

Primary outcomes:
measure: Cumulative Na+ excretion over 6 hours
timeFrame: 6 hours after lunch
Secondary outcomes:
measure: Fluid and Na+ excretion over the 6 hours
timeFrame: 6 hours after breakfast, 6 hours after lunch, and 24 hours]
measure: Creatinine clearance
timeFrame: While in the study (approximately 2 weeks)
measure: K+ excretion
timeFrame: While in the study (approximately 2 weeks)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Future Life Clinical Trials
state: Florida
Study officials:
affiliation: Safez Pharmaceuticals
name: Sophia Shah, MD
role: STUDY_DIRECTOR
affiliation: Future Life Clinical Trials
name: Nayle A Ancares, MD
role: PRINCIPAL_INVESTIGATOR
References: