Weight-Based Torsemide Dosing in Subjects With Heart Failure

NCT03187509 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2017-7615
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Torsemide, loop diuretics, weight-based

Outcome Measures

Primary Outcomes (1)

• 30-day all-cause readmission rate

  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

  30 days from enrollment

Secondary Outcomes (4)

• Effect size of weight based torsemide regimen compared to standard therapy

  30 days from enrollment

• Feasibility of a weight based torsemide regimen

  30 days from enrollment

• Incidence of acute kidney injury (AKI)

  30 days from enrollment

• Comparison of baseline changes of brain natriuretic peptide (BNP) levels

  30 days from enrollment

Study Arms (2)

Weight-Based Torsemide Group

EXPERIMENTAL

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

Standard Outpatient Management Group

ACTIVE COMPARATOR

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

Interventions

Torsemide DRUG

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.

Also known as: Demadex

Weight-Based Torsemide Group

Standard Outpatient Heart Failure Management OTHER

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.

Standard Outpatient Management Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Must be at least 18 years old at time of enrollment
• Must have reliable access to a telephone, and be able to speak and understand English or Spanish over a telephone connection

You may not qualify if:

• Any subject who is currently pregnant
• Any subject with end-stage renal disease requiring hemodialysis
• Any subject with serum potassium concentration \< 3.5 mEq/L at discharge
• Any subject with serum magnesium concentration \< 1.4 mg/dL at discharge
• Any subject with a known history of allergic reaction to loop diuretics
• Any subject with known severe stenotic valvular heart disease
• Any subject who requires chronic inotropic pharmacotherapy
• Any subject undergoing evaluation for cardiac transplantation or left-ventricular assist device
• Any subject who is not able to provide informed consent

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Jacobi Medical Cent

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Torsemide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert Siegel, MD

  Jacobi Medical Center, Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of CCU, Jacobi Medical Center, Assistant Professor of Medicine, Albert Einstein College of Medicine

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 15, 2017
• Study Start: April 17, 2018
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)