Trial Outcomes & Findings for Digoxin Dosing in Heart Failure: A Simplified Nomogram Versus Standard Care (NCT NCT01005602)
NCT ID: NCT01005602
Last Updated: 2014-05-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
131 participants
Primary outcome timeframe
Steady-state (2 - 4 weeks after initiation)
Results posted on
2014-05-22
Participant Flow
Participant milestones
| Measure |
Digoxin Dosing Per Nomogram
Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: 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).
|
Standard Digoxin Dosing
This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
|
Overall Study
COMPLETED
|
65
|
66
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Digoxin Dosing Per Nomogram
Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: 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).
|
Standard Digoxin Dosing
This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
|
|---|---|---|
|
Overall Study
Excluded due to unreliable clinical data
|
1
|
0
|
Baseline Characteristics
Digoxin Dosing in Heart Failure: A Simplified Nomogram Versus Standard Care
Baseline characteristics by cohort
| Measure |
Digoxin Dosing Per Nomogram
n=65 Participants
Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: 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).
|
Standard Digoxin Dosing
n=66 Participants
This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 15 • n=5 Participants
|
63 years
STANDARD_DEVIATION 15 • n=7 Participants
|
60 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ideal body weight
|
67 kg
STANDARD_DEVIATION 10 • n=5 Participants
|
62 kg
STANDARD_DEVIATION 11 • n=7 Participants
|
65 kg
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Total body weight
|
100 kg
STANDARD_DEVIATION 34 • n=5 Participants
|
85 kg
STANDARD_DEVIATION 27 • n=7 Participants
|
92 kg
STANDARD_DEVIATION 32 • n=5 Participants
|
|
Body Mass Index
|
33.2 kg/m^2
STANDARD_DEVIATION 10.4 • n=5 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 8.9 • n=7 Participants
|
31.6 kg/m^2
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Creatinine clearance
|
66 ml/min
STANDARD_DEVIATION 10 • n=5 Participants
|
51 ml/min
STANDARD_DEVIATION 22 • n=7 Participants
|
58 ml/min
STANDARD_DEVIATION 25 • n=5 Participants
|
|
Estimated Glomerular Filtration Rate
|
71 ml/min/1.73m^2
STANDARD_DEVIATION 22 • n=5 Participants
|
59 ml/min/1.73m^2
STANDARD_DEVIATION 23 • n=7 Participants
|
65 ml/min/1.73m^2
STANDARD_DEVIATION 23 • n=5 Participants
|
PRIMARY outcome
Timeframe: Steady-state (2 - 4 weeks after initiation)Outcome measures
| Measure |
Digoxin Dosing Per Nomogram
n=65 Participants
Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: 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).
|
Standard Digoxin Dosing
n=66 Participants
This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
|
TT Genotype
|
GA Genotype
|
|---|---|---|---|---|
|
Percent of Patients Achieving a Desired Steady-state Serum Digoxin Concentration Between 0.5 - 0.9ng/ml
|
38.5 percentage of participants
|
34.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Steady-state (2 - 4 weeks after initiation)Outcome measures
| Measure |
Digoxin Dosing Per Nomogram
n=65 Participants
Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: 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).
|
Standard Digoxin Dosing
n=66 Participants
This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
|
TT Genotype
|
GA Genotype
|
|---|---|---|---|---|
|
Mean Serum Digoxin Concentration
|
0.52 ng/ml
Standard Deviation 0.30
|
1.12 ng/ml
Standard Deviation 0.58
|
—
|
—
|
SECONDARY outcome
Timeframe: Steady-state (2 - 4 weeks after initiation)Outcome measures
| Measure |
Digoxin Dosing Per Nomogram
n=65 Participants
Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: 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).
|
Standard Digoxin Dosing
n=66 Participants
This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
|
TT Genotype
|
GA Genotype
|
|---|---|---|---|---|
|
Serum Digoxin Concentration < 1.0 ng/ml
|
86.2 percentage of participants
|
42.4 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Steady-state (2 - 4 weeks after initiation)55 patients in the Digoxin Dosing per Nomogram group consented to the Pharmacogenetic substudy and provided blood samples to perform pharmacogenetic analyses. We compared serum digoxin concentrations by ABCB1 genotype.
Outcome measures
| Measure |
Digoxin Dosing Per Nomogram
n=31 Participants
Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: 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).
|
Standard Digoxin Dosing
n=20 Participants
This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
|
TT Genotype
n=4 Participants
|
GA Genotype
|
|---|---|---|---|---|
|
Serum Digoxin Concentration by ABCB1 Single Nucleotide Polymorphism (SNP) C1236T
|
0.52 ng/ml
Standard Deviation 0.27
|
0.56 ng/ml
Standard Deviation 0.37
|
0.58 ng/ml
Standard Deviation 0.29
|
—
|
SECONDARY outcome
Timeframe: Steady-state (2 - 4 weeks after initiation)Serum digoxin concentration by genotypes for the ABCB1 SNP C3435T
Outcome measures
| Measure |
Digoxin Dosing Per Nomogram
n=27 Participants
Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: 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).
|
Standard Digoxin Dosing
n=25 Participants
This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
|
TT Genotype
n=3 Participants
|
GA Genotype
|
|---|---|---|---|---|
|
Serum Digoxin Concentration by ABCB1 SNP C3435T
|
0.54 ng/ml
Standard Deviation 0.28
|
0.54 ng/ml
Standard Deviation 0.35
|
0.46 ng/ml
Standard Deviation 0.07
|
—
|
SECONDARY outcome
Timeframe: Steady-state (2 - 4 weeks after initiation)Serum digoxin concentration by ABCB1 SNP genotypes
Outcome measures
| Measure |
Digoxin Dosing Per Nomogram
n=38 Participants
Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.
Dosing nomogram for digoxin: 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).
|
Standard Digoxin Dosing
n=12 Participants
This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
|
TT Genotype
n=3 Participants
|
GA Genotype
n=2 Participants
|
|---|---|---|---|---|
|
Serum Digoxin Concentration by ABCB1 SNP G2677T/A
|
0.54 ng/ml
Standard Deviation 0.27
|
0.50 ng/ml
Standard Deviation 0.42
|
0.66 ng/ml
Standard Deviation 0.30
|
0.40 ng/ml
Standard Deviation 0.13
|
Adverse Events
Digoxin Dosing Per Nomogram
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Digoxin Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert J. DiDomenico
University of Illinois at Chicago
Phone: (312) 413-4654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place