Digoxin Dosing in Heart Failure: A Simplified Nomogram Versus Standard Care

Completed · Phase 4

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01005602

Run by

University of Illinois at Chicago

People needed

131

Starts

2006-12-01

Expected to finish

2009-12-01

Last updated by the study team

2014-05-22

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 21 years
• Diagnosis of heart failure secondary to left ventricular dysfunction
• Receiving chronic digoxin therapy or digoxin therapy is being initiated

You may not qualify if…

• Pregnant
• Unstable renal function, defined as either a rise in serum creatinine by > 0.5mg/dl from baseline or a decrease in creatinine clearance by 25% or more within two to four weeks of study entry.
• End-stage renal disease requiring hemodialysis
• Concomitant therapy with drugs known to interact with digoxin (e.g., amiodarone, quinidine, verapamil, macrolide antibiotics)

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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