Weight-Based Torsemide Dosing in Subjects With Heart Failure

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York City Health and Hospitals Corporation
• Treatments: Diuretics; Natriuretic Peptide, Brain; Sodium Potassium Chloride Symporter Inhibitors; Torsemide

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