CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 131 enrolled
Drug / intervention
Digoxin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01005602
NCT01005602Phase 4Completed

Use of a Simplified Nomogram and Pharmacogenetics to Individualize Digoxin Dosing in Heart Failure Patients vs. Standard Care

University of Illinois at Chicago·interventional·Posted Nov 2, 2009·Updated May 22, 2014

In Brief

A Phase 4 clinical trial evaluating Digoxin Dosing per Nomogram and Digoxin for Heart Failure. Completed, enrolled 131 participants across 1 site.

Detailed Summary

Dosing methods for digoxin, a drug used to treat heart failure, have not been updated in decades despite evidence in recent years suggesting that blood levels of digoxin achieved with traditional dosing practices may increase the risk of adverse events. We developed a simple dosing tool that targets lower blood levels of digoxin that have been associated with improved outcomes compared to higher blood levels. The aim of this study is to determine if this simplified dosing tool is more effective than standard digoxin dosing practices at achieving lower blood levels and also to determine if digoxin dosing may be further optimized by incorporating patients' genetic information believed to influence the drug's properties.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2, 2009
Enrollment StartDec 1, 2006
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.7 years ago

Interventions

Digoxin Dosing per Nomogramother

Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis).

Digoxindrug

All patients included in the trial were treated with digoxin as clinically indicated. The intervention for this study required determining the digoxin dose via a proposed nomogram.