Table 1

Baseline Characteristics of Women in the Study Subgrouped According to SDC

CharacteristicPlaceboSDC (0.5–0.9 ng/ml)SDC (1.2–2.0 ng/ml)p Value
n75716289
Age (yrs)65 ± 1264 ± 1265 ± 120.509
Race (non-white) (%)1919150.547
BMI (kg/m2)27 ± 6.326 ± 6.227 ± 6.90.550
Previous digoxin use (%)4553530.085
Previous MI (%)5352560.786
Current angina (%)2927220.387
Hypertension (%)5453570.794
Ischemic etiology (%)6061610.933
Diabetes (%)3428350.318
NYHA functional class (%)
 I9912
 II515047
 III384033
 IV2180.961
ACE inhibitor9496960.687
Diuretic8886910.452
Nitrate4343450.936
Vasodilator therapy3.83.73.40.976
LVEF (U)30 ± 9.029 ± 9.029 ± 9.40.309
Duration of CHF (months)27 ± 3228 ± 3632 ± 320.303
SBP (mm Hg)128 ± 21130 ± 22125 ± 200.188
DBP (mm Hg)75 ± 1277 ± 1173 ± 100.031
Heart rate (beats/min)81 ± 1382 ± 1280 ± 120.586
CT ratio (%)0.56 ± 0.080.56 ± 0.070.58 ± 0.070.067
CHF score (U)12 ± 512 ± 514 ± 60.012
eGFR (ml/min/1.73 m2)60 ± 3464 ± 2154 ± 200.032
SDC (ng/ml)NA0.73 ± 0.131.44 ± 0.22<0.001
Time sample drawn (h)NA21 ± 7.418 ± 8.2<0.001

SDC groups based on samples obtained within 6 to 30 h after last dose of study drug. Results shown as mean ± SD where appropriate. p values represent significance testing across all three groups (see Results for pairwise comparison testing).

ACE = angiotensin converting enzyme; BMI = body mass index; CHF = congestive heart failure; CT = cardiothoracic; DBP = diastolic blood pressure; eGFR = estimated glomerular filtration rate; LVEF = left ventricular ejection fraction; MI = myocardial infarction; NYHA = New York Heart Association; SBP = systolic blood pressure; SDC = serum digoxin concentration.