Weight-Based Torsemide Dosing in Subjects With Heart Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 11/11/2018 |
| Start Date: | April 17, 2018 |
| End Date: | June 2020 |
| Contact: | Robert Siegel, MD |
| Email: | robert.siegel@nychhc.org |
| Phone: | 718-918-5900 |
Weight-Based Torsemide Dosing vs. Standard Outpatient Management in Subjects With Heart Failure: A Randomized Open-Label Pilot Study
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.
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.
Inclusion Criteria:
1. All subjects with admission diagnosis of heart failure, including heart failure with
reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) treated with
loop diuretics during hospitalization
2. Must be at least 18 years old at time of enrollment
3. Must have reliable access to a telephone, and be able to speak and understand English
or Spanish over a telephone connection
Exclusion Criteria:
1. Any subject who is currently pregnant
2. Any subject with end-stage renal disease requiring hemodialysis
3. Any subject with serum potassium concentration < 3.5 mEq/L at discharge
4. Any subject with serum magnesium concentration < 1.4 mg/dL at discharge
5. Any subject with a known history of allergic reaction to loop diuretics
6. Any subject with known severe stenotic valvular heart disease
7. Any subject who requires chronic inotropic pharmacotherapy
8. Any subject undergoing evaluation for cardiac transplantation or left-ventricular
assist device
9. Any subject who is not able to provide informed consent
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