Phase 4
Completed N=132
Digoxin Dosing in Heart Failure: A Simplified Nomogram Versus Standard Care
Source: ClinicalTrials.gov NCT01005602 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Percent of Patients Achieving a Desired Steady-state Serum Digoxin Concentration Between 0.5 - 0.9ng/ml — 38.5; 34.8 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Achieving a Desired Steady-state Serum Digoxin Concentration Between 0.5 - 0.9ng/ml |
38.5; 34.8 | — |
| SECONDARY Mean Serum Digoxin Concentration |
0.52; 1.12 | — |
| SECONDARY Serum Digoxin Concentration < 1.0 ng/ml |
86.2; 42.4 | — |
| SECONDARY Serum Digoxin Concentration by ABCB1 Single Nucleotide Polymorphism (SNP) C1236T |
0.52; 0.56; 0.58 | — |
| SECONDARY Serum Digoxin Concentration by ABCB1 SNP C3435T |
0.54; 0.54; 0.46 | — |
| SECONDARY Serum Digoxin Concentration by ABCB1 SNP G2677T/A |
0.54; 0.50; 0.66; 0.40 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 21 years
- Diagnosis of heart failure secondary to left ventricular dysfunction
- Receiving chronic digoxin therapy or digoxin therapy is being initiated
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01005602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.