“Weight-Based Torsemide Dosing in Subjects With Heart Failure”
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.
Drug - Torsemide
These subjects who are randomized to a weight-based torsemide regimen will be instructed via phone encounters three times per week to take an individualized dose of torsemide based on their current weight and symptoms. These subjects will have a follow-up study appointment at week 5 for a final weight and blood work to assess kidney function, electrolytes and brain-natriuretic peptide levels.
Standard Outpatient Heart Failure Management
Those subjects randomized to standard outpatient management group will be prescribed a daily fixed dose of a loop diuretic upon discharge from the hospital. These subjects will have a follow-up appointment within one week of discharge where all medications including loop diuretic type, dose and frequency will be managed at the discretion of the subject's physician. These subjects will also have a follow-up study appointment at week 5 for a final weight and blood work to assess kidney function, e ...read more on ClinicalTrials.org
Weight-Based Torsemide Dosing vs. Standard Outpatient Management in Subjects With Heart Failure: A Randomized Open-Label Pilot Study