Table 1.
Baseline characteristics of the overall cohort and patients with and without improvement in renal function
| Characteristics | Overall Cohort (n=980) |
No IRF (n=828) |
Yes IRF (n=152) |
p | IRF and | p | |
|---|---|---|---|---|---|---|---|
| Placebo (n=60) |
Digoxin (n=92) |
||||||
| Demographics | |||||||
| Age | 63.4 ± 10.5 | 63.8 ± 10.2 | 61.6 ± 11.8 | 0.021* | 60.0 ± 12.7 | 62.7 ± 11.2 | 0.170 |
| White race | 88.6% | 89.3% | 84.9% | 0.118 | 86.7% | 83.7% | 0.617 |
| Male | 78.6% | 80.1% | 70.4% | 0.008* | 66.7% | 72.8% | 0.416 |
| Past Medical History | |||||||
| Hypertension | 43.0% | 42.6% | 44.7% | 0.630 | 41.7% | 46.7% | 0.539 |
| Diabetes mellitus | 25.4% | 25.6% | 24.3% | 0.743 | 18.3% | 28.3% | 0.163 |
| Angina | 26.0% | 26.3% | 24.3% | 0.608 | 21.7% | 26.1% | 0.535 |
| Prior myocardial infarction | 68.4% | 68.8% | 65.8% | 0.457 | 60.0% | 69.6% | 0.224 |
| Physical Examination | |||||||
| Heart rate | 76.5 ± 12.6 | 76.4 ± 12.6 | 77.4 ± 12.9 | 0.382 | 77.9 ± 12.7 | 77.0 ± 13.1 | 0.657 |
| Systolic blood pressure (mmHg) | 126.6 ± 20.2 | 126.9 ± 20.2 | 124.8 ± 19.7 | 0.247 | 123.0 ± 20.1 | 126.0 ± 19.5 | 0.360 |
| Pulmonary crackles | 71.0% | 70.9% | 71.7% | 0.838 | 71.7% | 71.7% | 0.992 |
| S3 gallop | 49.4% | 49.4% | 49.3% | 0.990 | 41.7% | 54.3% | 0.126 |
| Edema | 50.2% | 48.9% | 57.2% | 0.059 | 61.7% | 54.3% | 0.373 |
| Jugular venous distention | 52.2% | 51.0% | 59.2% | 0.061 | 60.0% | 58.7% | 0.873 |
| Medications (Baseline) | |||||||
| Prior digoxin | 49.9% | 49.8% | 50.7% | 0.838 | 45.0% | 54.3% | 0.260 |
| ACE inhibitor | 96.2% | 96.1% | 96.7% | 0.732 | 96.7% | 96.7% | 0.980 |
| Potassium sparing diuretic | 11.5% | 11.1% | 13.8% | 0.337 | 18.3% | 10.9% | 0.192 |
| Other diuretic | 75.7% | 75.6% | 76.3% | 0.851 | 76.7% | 76.1% | 0.935 |
| Nitrates | 36.2% | 35.5% | 40.1% | 0.276 | 40.0% | 40.2% | 0.979 |
| Hydralazine | 1.0% | 1.0% | 1.3% | 0.693 | 0.0% | 2.2% | 0.250 |
| Laboratory Value (baseline) | |||||||
| eGFR (mL/min/1.73m2) | 70.0 ± 21.7 | 71.4 ± 22.3 | 62.1 ± 15.3 | <0.001* | 63.7 ± 15.9 | 61.1 ± 15.0 | 0.297 |
| Serum creatinine (mg/dL) | 1.3 ± 0.4 | 1.3 ± 0.4 | 1.3 ± 0.3 | 0.001* | 1.3 ± 0.3 | 1.4 ± 0.3 | 0.339 |
| Laboratory Value (one year) | |||||||
| eGFR (mL/min/1.73m2) | 68.4 ± 21.2 | 65.6 ± 19.9 | 83.3 ± 21.8 | <0.001* | 85.2 ± 22.4 | 82.0 ± 21.4 | 0.384 |
| Serum creatinine (mg/dL) | 1.3 ± 0.4 | 1.4 ± 0.5 | 1.0 ± 0.2 | <0.001* | 1.0 ± 0.3 | 1.1 ± 0.2 | 0.429 |
| Serum digoxin (ng/ml) † | 0.8 ± 0.6 | 0.9± 0.6 | 0.8 ± 0.5 | 0.078 | 0.0 ± 0.0 | 0.8 ± 0.5 | <0.001* |
| Serum digoxin level ≤0.08 ng/ml † | 54.7% | 52.2% | 66.7% | 0.014* | N/A | 66.7% | N/A |
| Change in eGFR (mL/min/1.73m2) | 1.6 ± 17.5 | −5.8 ± 15.2 | 21.2 ± 10.2 | <0.001* | 21.5 ± 10.7 | 21.0 ± 9.9 | 0.771 |
| Change in eGFR (%) | 0.6 ± 21.9 | −7.0 ± 15.9 | 34.5 ± 15.4 | <0.001* | 34.2 ± 15.4 | 34.7 ± 15.5 | 0.850 |
| Functional Status / Imaging | |||||||
| Ejection fraction (%) | 31.6 ± 12.2 | 31.5 ± 11.9 | 32.3 ± 13.7 | 0.481 | 32.5 ± 14.3 | 32.2 ± 13.4 | 0.887 |
| Preserved ejection fraction (>45%) | 11.7% | 11.0% | 15.8% | 0.091 | 20.0% | 13.0% | 0.250 |
| Cardio-thoracic ratio | 0.51 ± 0.07 | 0.52 ± 0.07 | 0.53 ± 0.07 | 0.082 | 0.53 ± 0.06 | 0.53 ± 0.07 | 0.806 |
| New York Heart Association class | 2.1 ± 0.7 | 2.1 ± 0.7 | 2.2 ± 0.7 | 0.090 | 2.3 ± 0.7 | 2.2 ± 0.7 | 0.157 |
ACE: Angiotensin converting enzyme inhibitor. Improvement in renal function (IRF) defined as ≥ 20% improvement in estimated glomerular filtration rate (eGFR) from randomization to one year.
*
Significant p value
†
Analysis restricted to patients randomized to digoxin.