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Report for Clinical Trial NCT01005602

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT01005602 Heart Failure
MeSH: Heart Failure
HPO: Congestive heart failure Left ventricular dysfunction Right ventricular failure

2 Interventions

Name: Digoxin Dosing per Nomogram

Description: 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).

Type: Other

Digoxin Dosing per Nomogram

Name: Digoxin

Description: 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.

Type: Drug

Digoxin Dosing per Nomogram Standard Digoxin Dosing


Primary Outcomes

Measure: Percent of Patients Achieving a Desired Steady-state Serum Digoxin Concentration Between 0.5 - 0.9ng/ml

Time: Steady-state (2 - 4 weeks after initiation)

Secondary Outcomes

Measure: Mean Serum Digoxin Concentration

Time: Steady-state (2 - 4 weeks after initiation)

Measure: Serum Digoxin Concentration < 1.0 ng/ml

Time: Steady-state (2 - 4 weeks after initiation)

Description: 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.

Measure: Serum Digoxin Concentration by ABCB1 Single Nucleotide Polymorphism (SNP) C1236T

Time: Steady-state (2 - 4 weeks after initiation)

Description: Serum digoxin concentration by genotypes for the ABCB1 SNP C3435T

Measure: Serum Digoxin Concentration by ABCB1 SNP C3435T

Time: Steady-state (2 - 4 weeks after initiation)

Description: Serum digoxin concentration by ABCB1 SNP genotypes

Measure: Serum Digoxin Concentration by ABCB1 SNP G2677T/A

Time: Steady-state (2 - 4 weeks after initiation)

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 3 SNPs

SNPs


1 C1236T

Serum Digoxin Concentration by ABCB1 Single Nucleotide Polymorphism (SNP) C1236T. --- C1236T ---


2 C3435T

We compared serum digoxin concentrations by ABCB1 genotype.. Serum Digoxin Concentration by ABCB1 SNP C3435T. --- C3435T ---

Serum digoxin concentration by genotypes for the ABCB1 SNP C3435T. --- C3435T ---


3 G2677T

Serum Digoxin Concentration by ABCB1 SNP G2677T/A. --- G2677T ---



HPO Nodes


HPO:
Congestive heart failure
Genes 250
PTEN HJV BAZ1B PEX7 HBA1 ND1 TNNT2 TRIM37 ACAD9 AGPAT2 TRNS1 LMNA EYA4 ND4 MYH7 LMNA RFC2 DSP NDUFAF3 TMEM43 SF3B1 HADHB SLC25A11 COX2 ENG HBA2 CEP19 LMNA TRNQ TRNQ GTF2IRD1 IDS MYL3 MYH7 ATXN7 ND6 HNRNPA1 CACNA1S FLNC XYLT2 EPG5 BSCL2 MYH6 FBN1 TRNK GBA SLC2A10 TRNV COX3 RET PRKAR1A MDH2 TRNK IRF5 MYH7 GPR35 TRNL1 ENG SURF1 STAT1 NSMCE2 SGCD ATP5F1A PLN TUBB PLOD1 CAV3 SLC25A26 SLC19A2 MYD88 GLA TPM1 GNPTAB RBM20 LMNA CDH23 TRNW CLIP2 MYPN TSC1 BMP2 HAMP TRNF ADCY5 LMNA LDB3 TTN ELN ENPP1 CAVIN1 TF MAX ELAC2 NDUFS2 CYTB DES DMD MYLK2 MAX TBL2 HLA-DRB1 ALMS1 PNPLA2 SLC17A5 COG7 SLC22A5 MYH7 PSMB8 SCN1B EYA4 MST1 FH TMEM127 MYH7 ND6 PPARG SDHA MAPRE2 COX1 JUP PSEN2 RASA1 ND5 SLC25A3 LMNA DLST TRNF IFIH1 ADCY5 SDHB SCN4A FXN GDF2 GTF2I HADHA GJA1 GNA11 RYR1 HFE SNAP29 TRNH TNNI3K FLNA TRNS2 SDHAF2 LMNA ACVRL1 TSC2 CASR FOS FGFR3 TRNK TRNL1 BCHE CCR6 CAV1 FGF23 VHL TMEM70 ADAMTSL2 DTNA PRKAG2 BAG3 TRNE SMAD4 TRNS2 ACAD9 SDHC PRKAR1A TAZ CAV1 ALMS1 TRNS1 NDUFB8 LIMK1 CLIC2 GATAD1 SDHD NDUFAF1 PRDM16 SELENON TRPM4 ACTC1 PRKAR1A SCN5A RPS19 TRIP4 FBLN5 SDHB NDUFB11 ATP6V1A HNRNPA2B1 CCN2 PSMB8 PPA2 TRNL1 COX1 RAB3GAP2 TNNI3 HFE COL1A2 TRNC CLIC2 DSP ND1 SCO2 JUP SDHD TRNW COX3 EFEMP2 AGGF1 TMEM127 TCF4 LMNA DSP KIF1B COL1A1 COX2 TPI1 GNPTAB FGD1 PSEN1 RET GLB1 KCNJ5 PHYH DES GTPBP3 HADHB WRN ND5 MECP2 HADHA GDNF VCL GLA TTN KIF1B VHL VCP ABCC6 PPARG CP XYLT1 TET2 DNAJC19 IKBKG NKX2-5 ABCC6
Left ventricular dysfunction
Genes 67
TRNL1 SDHAF1 LDLRAP1 LDLR FBN1 RYR2 APOB POMT1 MAT2A FKRP LMNA TOP3A TRNW ABCG8 TRNC ND1 TRNS2 MYH7 LDB3 TRNS1 TTN POLG2 EYA4 POMT2 FOXE3 SMAD4 TGFBR2 SGCG PPCS DYSF TRNK CYTB TRDN SMAD3 MYH11 POLG ACTA2 COX2 SLC25A4 SDHD TGFB3 PRKG1 MYLK TWNK TRNQ SDHB POMT2 LAMA2 RRM2B ND6 MYH11 TGFB2 ND5 ELN COX1 MFAP5 PRDM16 TRNV SDHA COX3 MYH11 TRNF LOX PCSK9 CASQ2 TGFBR1 ABCG5
Right ventricular failure
Genes 7
DAXX SDHD TTN BMPR2 MYH7 SELENON ATRX