Weight-Based Torsemide Dosing in Subjects With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This study will be an open-label parallel randomized pilot study comparing an individualized
      weight-based torsemide dosing regimen vs. standard outpatient management in patients with a
      diagnosis of heart failure.The study will include consenting subjects who are admitted to
      Jacobi Medical Center with heart failure and were treated with loop diuretic therapy during
      hospitalization. Prior to discharge, these subjects will be randomized to one of two groups,
      either an individualized weight-based torsemide regimen group vs. a standard heart failure
      management group.

      After randomization, all subjects will undergo an initial assessment prior to discharge. All
      subjects will be examined, weighed and assigned a composite congestion score (CCS). CCS is a
      measurement of current fluid status that has been shown to correlate with clinical outcomes
      in heart failure patients (19). It assesses a patient's signs and symptoms of congestion,
      including dyspnea, orthopnea, fatigue, jugular venous distention, rales and peripheral edema.
      Each category is given a score from 0-3, 0=none, 1=mild,2=moderate and 3=severe. Each subject
      is given a final composite score for their current volume status.

      After discharge, those randomized to standard care will receive standard heart failure care
      as currently provided in our institution. This routinely includes, but is not limited to, an
      appointment with their primary care physician within one week of discharge, nutrition
      consultation, and social work evaluation with support services provided as determined by the
      social worker. At discharge, all heart failure medication changes including diuretic type,
      dose and frequency, as well as further management decisions, will be left to the discretion
      of the subject and the subject's doctors. Those who will be randomized to the individualized
      weight-based torsemide regimen will be given a standup home scale and torsemide 20mg tabs in
      a bottle with 100 tablets.

      An initial torsemide dose will be assigned based on the patient's GFR and CCS at discharge.
      These subjects will then have a phone encounter with a physician three times a week where
      subjects will be instructed to modify the torsemide dose based on their current weight.
      Patients will be instructed to weigh themselves at the same time of the day, postvoid, prior
      to eating, prior to the medication dose, and while wearing the same clothing for consistency.
      The scales should stand on a flat, solid surface rather than carpets unless specifically
      designed for use in that setting. All phone call encounters and loop diuretic changes will be
      based on the pre-specified algorithm. These subjects will also receive all the same care and
      support as a standard subject, including the primary care appointment in one week and other
      support services, except with instructions to the subject and provider to follow the loop
      diuretic recommendations from this protocol. Subjects who have been instructed to take more
      than 80 torsemide 20mg tablets will receive a delivery of 100 additional torsemide 20mg
      tablets.

      All subjects in the study will have follow up visit at week 5 from discharge date. Total
      diuretic use during the study period will be assessed and current symptoms/quality of life
      will be evaluated using the Kansas City Cardiomyopathy Questionnaire. The patient will
      receive a physical examination including a final weight and calculation of composite
      congestion score. Serum B-type natriuretic peptide (BNP) will be obtained as well as a basic
      metabolic panel and serum magnesium level to assess for electrolyte disturbances and changes
      in kidney function. Intervention group subjects will have a count of the remaining number of
      torsemide tablets in the bottle of torsemide given to them at discharge. Compliance with the
      algorithm will be assessed by comparing the number of remaining tablets with the number of
      tablets prescribed during the study. Subjects whose follow-up visit occurs over 45 days after
      the date of hospital discharge for the enrollment hospitalization shall be deemed to be late
      for follow-up. Acute kidney injury (AKI) will be defined as an increase in serum creatinine
      concentration of 0.3 at the five-week follow-up visit compared to the final serum creatinine
      level measured during hospitalization. Adherence will be measured by comparing the number of
      tablets in the subject's torsemide supply to the number of expected tablets in the torsemide
      supply. Adherence will be defined as a tablet count consistent with the subject having taken
      88% or more of the expected torsemide tablets
    

Intervention name(s): Torsemide; Standard Outpatient Heart Failure Management
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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, electrolytes and brain-natriuretic peptide levels.
Other intervention name(s): Demadex
Intervention MeSH terms: Torsemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Torsemide, loop diuretics, weight-based