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Weight-Based Torsemide Dosing in Subjects With Heart Failure

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ClinicalTrials.gov Identifier: NCT03187509
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Siegel, New York City Health and Hospitals Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Torsemide Other: Standard Outpatient Heart Failure Management Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weight-Based Torsemide Dosing vs. Standard Outpatient Management in Subjects With Heart Failure: A Randomized Open-Label Pilot Study
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Torsemide

Arm Intervention/treatment
Experimental: Weight-Based Torsemide Group
Subjects will be randomized to complete a weight-based torsemide dosing regimen for their outpatient heart failure management. These subjects will prescribed a specified dose of torsemide on discharge from the hospital and subsequently have a phone encounter with a physician three times a week where their dose of torsemide will be titrated based on an algorithm which factors in current symptoms and weight. Study subjects will have a final follow-up appointment at the completion of the study to evaluate current symptoms, weight and perform blood work to assess kidney function, electrolytes and brain natriuretic peptide levels.
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.
Other Name: Demadex

Active Comparator: Standard Outpatient Management Group
Subjects will be randomized to standard outpatient heart failure management where they will be prescribed a fixed daily dose of a loop diuretic upon discharge from the hospital and have a follow-up appointment within one week of discharge. All medications including loop diuretic type, dose and frequency will be managed at the discretion of the patient's primary care physician or cardiologist. Study subjects will have a final follow-up appointment at the completion of the study to evaluate current symptoms, weight and perform blood work to assess kidney function, electrolytes and brain natriuretic peptide levels.
Other: 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, electrolytes and brain-natriuretic peptide levels.




Primary Outcome Measures :
  1. 30-day all-cause readmission rate [ Time Frame: 30 days from enrollment ]
    To gain an unbiased estimate of 30-day all-cause hospital readmission rate with an individualized weight-based torsemide dosing regimen and with standard therapy


Secondary Outcome Measures :
  1. Effect size of weight based torsemide regimen compared to standard therapy [ Time Frame: 30 days from enrollment ]
    To obtain a preliminary estimate of the effect size of an individualized weight-based torsemide regimen intervention using contemporaneous controls of standard care for planning a potential, larger future study

  2. Feasibility of a weight based torsemide regimen [ Time Frame: 30 days from enrollment ]
    To assess the feasibility of subjects to follow an individualized weight-based torsemide regimen as assessed by compliance with study medications, adhering to thrice weekly phone encounters and following medication dose modifications based on the study algorithm. Compliance with the study medication and algorithm will be assessed at the final study appointment by comparing the number of remaining torsemide tablets in the subject's pill box which was provided at the beginning of the study with the number of tablets prescribed during the study.

  3. Incidence of acute kidney injury (AKI) [ Time Frame: 30 days from enrollment ]
    To gain an unbiased estimate of AKI incidence, as defined by an increase serum creatinine by ≥0.3 mg/dL from baseline, with an individualized weight-based torsemide dosing regimen and with standard therapy

  4. Comparison of baseline changes of brain natriuretic peptide (BNP) levels [ Time Frame: 30 days from enrollment ]
    To compare changes in BNP(pg/mL) levels from baseline in subjects randomized to a weight-based torsemide regimen and those randomized to standard therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187509


Contacts
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Contact: Robert Siegel, MD 718-918-5900 robert.siegel@nychhc.org
Contact: Jeremy Miles, MD milesj@nychhc.org

Locations
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United States, New York
Jacobi Medical Cent Recruiting
Bronx, New York, United States, 10461
Contact: Robert M Seigel, MD    718-918-5900      
Sponsors and Collaborators
New York City Health and Hospitals Corporation
Investigators
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Principal Investigator: Robert Siegel, MD Jacobi Medical Center, Albert Einstein College of Medicine

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Responsible Party: Robert Siegel, Director of CCU, Jacobi Medical Center, Assistant Professor of Medicine, Albert Einstein College of Medicine, New York City Health and Hospitals Corporation
ClinicalTrials.gov Identifier: NCT03187509    
Other Study ID Numbers: 2017-7615
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Robert Siegel, New York City Health and Hospitals Corporation:
Torsemide, loop diuretics, weight-based
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Torsemide
Natriuretic Peptide, Brain
Diuretics
Sodium Potassium Chloride Symporter Inhibitors
Natriuretic Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents