NCT03187509

Weight-Based Torsemide Dosing in Subjects With Heart Failure

Completed Phase 4 Last updated 15 March 2022

What this trial tests

Phase 4 trial testing Torsemide in Heart Failure in 52 participants. Completed in 14 March 2022.

Timeline

17 April 2018

Primary endpoint
14 March 2022

14 March 2022

Quick facts

Lead sponsor	New York City Health and Hospitals Corporation
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	17 April 2018
Primary completion	14 March 2022
Estimated completion	14 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Torsemide — full drug profile →
• Standard Outpatient Heart Failure Management

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

New York City Health and Hospitals Corporation

Who can join

Adults 18 to 90, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.