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

NCT01005602 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2014-05-22

Study results available
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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.

Conditions

Interventions

OTHER

Digoxin Dosing per Nomogram

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).

DRUG

Digoxin

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.

Sponsors & Collaborators

  • American College of Clinical Pharmacy

    collaborator OTHER

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Robert J DiDomenico, PharmD · University of Illinois at Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01005602 on ClinicalTrials.gov