Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03187509 |
Other study ID # |
2017-7615 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
April 17, 2018 |
Est. completion date |
March 14, 2022 |
Study information
Verified date |
March 2022 |
Source |
New York City Health and Hospitals Corporation |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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