Weight-Based Torsemide Dosing in Subjects With Heart Failure
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
This study will be a randomized open-label pilot study. The purpose of the study is to
compare standard of care outpatient heart failure management versus a weight based torsemide
regimen. Subjects admitted to the hospital for heart failure exacerbation will be randomized
upon discharge to either standard of care outpatient heart failure management or a weight
based torsemide regimen. Those subjects randomized to standard of care therapy will be
prescribed a daily fixed dose of a loop diuretic at hospital discharge and have a follow-up
appointment within one week of discharge. All management decisions including loop diuretic
type, dose and frequency will be made at the discretion of the subject's personal physician.
Those randomized to an individualized weight based torsemide regimen will be prescribed a
dose of torsemide upon hospital discharge based on a prespecified algorithm. These subjects
will then undergo physician-subject phone encounters three times a week where the subject's
torsemide dose will be modified based on the prespecified algorithm which incorporates
current symptoms and weight. Primary end-point will be an unbiased estimate of 30-day all
cause readmission rates. Secondary end-points include incidence of acute kidney injury,
changes in brain natriuretic peptide levels from baseline and a preliminary estimate of the
effect size and feasibility of a weight-based torsemide regimen intervention in order to plan
a future larger study.