Immediate Release Versus Extended Release Torsemide After Salty Meal
Status:
Recruiting
Trial end date:
2025-08-01
Target enrollment:
Participant gender:
Summary
The goal of this randomized double-blind crossover study is to assess whether a morning dose
of the extended release torsemide has a better efficacy than the ordinary immediate release
torsemide to induce renal sodium excretion after a salty lunch in patients with stable heart
failure. The main questions it aims to answer are:
- Are the amounts of excreted sodium in the urine during the 2- and 6-hours' time period
after a morning dose of extended release torsemide different from the amounts after the
immediate release torsemide.
- Are 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, different from the amounts after the immediate
release torsemide.
- Is 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, different from the amount after the immediate release
torsemide.
Participants will be asked to:
- Start taking daily immediate release or extended release torsemide tablets that is
provided to them.
- Eat the meals with standard contents of sodium that is provided to them and avoid other
meals, drinks (except for water) and snacks for the duration of the study.
- Collect urine for 24 hours, after approximately one week of the initiation of the study
medication.
- Go to the clinical research center the day that the 24-hour urine collection is finished
and stay there throughout the day to receive standard meals and to have blood and urine
samples collected.
- Switch torsemide pills to the new one that will be dispensed to them at the clinical
research center. If they were taking the immediate release torsemide during the first
part, then they will be given the sustained release torsemide and vice versa. The study
is double blind; therefore, the subjects, study coordinators, and investigators are
unaware of whether each subject is on immediate release torsemide first or on extended
release torsemide first.
- Collect urine for an additional 12 hours after leaving the clinical research center to
be sent to the clinical research center the next morning.
- Continue to take the provided meals and to avoid other meals, drinks (except for water)
and snacks.
- Again, collect urine for 24 hours, after approximately one week, take that to the
clinical research center when the 24-hour collection is completed and stay there
throughout the day to receive standard meals and to have blood and urine samples
collected.
- Collect urine for an additional 12 hours to be sent to the clinical research center the
next morning.
Researchers will compare the amount of sodium excretion when each subject is taking immediate
release torsemide versus the time that the same subject is taking extended release torsemide.