Heart Failure
Conditions
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.
Interventions
DRUGtorsemide
Extended release formulation of torsemide
Sponsors
Sarfez Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention model description
Double-blind, double-dummy, two-period, two arm, randomized, crossover clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Na+ excretion over 6 hours | 6 hours after lunch | The primary outcome is the cumulative Na+ excretion over 6 hours after lunch. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluid and Na+ excretion over the 6 hours | 6 hours after breakfast, 6 hours after lunch, and 24 hours] | Fluid and Na+ excretion over the 6 hours after breakfast, 6 hours after lunch, and 24 hours after dosing. |
| Creatinine clearance | While in the study (approximately 2 weeks) | Safety outcome |
| K+ excretion | While in the study (approximately 2 weeks) | Safety outcome |
Countries
United States
Outcome results
None listed