Table 2.
Changes in Parameters during Trial
| Placebo
|
Epoetin Alfa
|
Adjusted P Value Between Group Comparison* | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n | Baseline | n | Change at 3 months | n | Change at 6 months | n | Baseline | n | Change at 3 months | n | Change at 6 months | ||
| Hemodynamics | |||||||||||||
| Systolic BP (mm Hg) | 28 | 140 (15) | 27 | −4.8 (25) | 22 | −5.86 (22) | 28 | 146 (17) | 22 | −0.59 (22) | 22 | −2 (27) | 0.81 |
| Diastolic BP (mm Hg) | 28 | 65 (11) | 27 | −3 (13) | 22 | −0.2 (9) | 28 | 67 (11) | 22 | −2 (12) | 22 | 2 (11) | 0.80 |
| Laboratory | |||||||||||||
| Hemoglobin (mg/dL) | 28 | 10.4 (0.9) | 26 | +0.7 (1.0) | 22 | 0.5 (1.0) | 28 | 10.6 (1.1) | 22 | 1.7 (1.4)† | 21 | 1.2 (1.2)† | 0.03 |
| Creatinine (mg/dL) | 28 | 1.5 (0.8) | 27 | 0.03 (0.4) | 24 | −0.03 (0.4) | 28 | 1.6 (0.7) | 22 | 0.1 (0.3) | 22 | 0.1 (0.4) | 0.61 |
| BUN (mg/dl) | 28 | 37 (16) | 27 | −1 (15) | 24 | −1 (17) | 28 | 33 (17) | 22 | 3 (16) | 22 | 3 (17) | 0.66 |
| eGFR (ml/min) | 28 | 48 (18) | 27 | 0.4 (18) | 24 | 1.0 (13) | 28 | 46 (19) | 22 | −3 (9) | 22 | −2 (9) | 0.83 |
| BNP (pg/mL) | 28 | 373 (336) | 27 | −60 (166) | 24 | −67 (256) | 28 | 488 (392) | 22 | 26 (273) | 20 | −13 (348) | 0.81 |
| Quality of Life | |||||||||||||
| KCCQ | 28 | 62 (22) | 27 | 13 (16)† | 24 | 16 (19)† | 27 | 58 (28) | 22 | 9 (19)† | 22 | 15 (24)† | 0.90 |
| MLWFQ | 28 | 32 (22) | 27 | −12 (16)† | 24 | −10 (22)† | 27 | 35 (25) | 22 | −7 (19)† | 22 | −11 (21)† | 0.80 |
| GDS | 28 | 7 (5) | 24 | −0.5 (4) | 24 | 0.7 (5) | 28 | 10 (7) | 22 | −1.0 (4) | 22 | −0.7 (4) | 0.95 |
| WOMAC | 28 | 41 (28) | 27 | −6 (19) | 24 | −7 (30) | 28 | 44 (29) | 22 | −7 (17) | 22 | −7 (21) | 0.95 |
| Three Dimensional Echocardiography | |||||||||||||
| LV ejection fraction (%) | 27 | 58 (9) | 27 | 3 (7)% | 23 | 4 (8) | 26 | 58 (10) | 21 | 1 (7)% | 20 | −2 (8) | 0.18 |
| LV end diastolic volume (ml) | 27 | 99 (28) | 27 | 0.03 (10) | 23 | −4 (16) | 26 | 98 (32) | 21 | −5 (9) | 20 | −6 (14) | 0.67 |
| Stroke Volume (ml) | 27 | 56 (13) | 27 | 3.9 (10) | 23 | 3 (9) | 26 | 56 (15) | 21 | −2 (7)† | 20 | −5 (8)† | 0.09 |
| LV end systolic volume (ml) | 27 | 43 (19) | 27 | −4 (9) | 23 | −7 (13) | 26 | 42 (22) | 21 | −3 (8) | 20 | −1 (12) | 0.61 |
| Mean e′ velocity (cm/s) | 27 | 6.5 (2.6) | 24 | −0.3 (1.9) | 21 | −1.1 (2.5) | 27 | 6.5 (3.2) | 20 | 0.5 (2.8) | 18 | −0.7 (3.5) | 0.61 |
| E-velocity/e′ | 27 | 19 (10) | 24 | 3 (8) | 21 | 3 (7) | 26 | 19 (15) | 20 | 0 (6) | 18 | −1 (11) | 0.61 |
| Pressure Volume Relations | |||||||||||||
| Estimated LVEDP (mm Hg) | 27 | 23 (6) | 24 | 1.75 (5) | 19 | 0.3 (4) | 26 | 24 (9) | 20 | 0.35 (4) | 18 | −0.4 (5) | 0.83 |
| Stroke Work | 27 | 5161 (1309) | 27 | 333 (839) | 23 | 211 (896) | 26 | 5374 (1610) | 21 | −120 (615) | 20 | −455 (675) | 0.09 |
| Stroke Work/LV mass | 27 | 53 (15) | 27 | 4 (8) | 23 | 2 (13) | 26 | 52 (14) | 21 | −3 (7)* | 20 | −4 (7)* | 0.32 |
| Functional | |||||||||||||
| 6-Minute walk (m) | 27 | 239 (102) | 26 | 9 (69) | 23 | 5 (59) | 27 | 242 (97) | 21 | 14 (51) | 21 | 16 (47) | 0.50 |
| VO2 (ml/kg/min) | 9 | 10.3 (2.9) | 7 | −0.9 (1.8) | 6 | −1.2 (1.4) | 10 | 9.0 (2.5) | 5 | 0.7 (2.1) | 4 | 1.0 (1) | 0.03 |
| RER | 9 | 1.1 (0.1) | 7 | −0.01 (0.1) | 6 | −0.04 (0.1) | 10 | 1.0 (0.2) | 5 | 0.04 (0.1) | 4 | 0.03 (0.08) | 0.95 |
| VE (ml) | 8 | 31 (8) | 6 | −0.9 (4) | 5 | −5 (8) | 8 | 24 (7) | 4 | −1.0 (3) | 3 | −2 (2) | 0.81 |
| VE/VCO2 | 9 | 34 (6) | 7 | 2.1 (7) | 6 | 0.2 (3) | 10 | 38 (16) | 5 | −0.6 (8) | 4 | −3 (7) | 0.61 |
| Blood Volume | |||||||||||||
| Red cell volume (ml) | 24 | 1323 (288) | N/A | N/A | 17 | 58 (237) | 20 | 1454 (433) | N/A | N/A | 15 | 173 (164) | 0.13 |
| Plasma Volume (ml) | 24 | 3264 (701) | N/A | N/A | 17 | 14 (287) | 20 | 3710 (975) | N/A | N/A | 15 | −206 (299)† | 0.04 |
| Total Blood Volume (ml) | 24 | 4586 (950) | N/A | N/A | 17 | 66 (433) | 20 | 5163 (1379) | N/A | N/A | 15 | −32 (318) | 0.40 |
| Red cell volume (%) | 24 | −18 (9) | N/A | N/A | 17 | 2 (13) | 20 | −18 (17) | N/A | N/A | 15 | 10 (10) | 0.07 |
| Plasma Volume (%) | 24 | 24 (22) | N/A | N/A | 17 | 0 (10) | 17 | 22 (20) | N/A | N/A | 15 | −6 (10) | 0.23 |
| Total Blood Volume (%) | 24 | 8 (15) | N/A | N/A | 17 | 1 (9) | 20 | 10 (18) | N/A | N/A | 15 | 0.3 (5) | 0.80 |
*
P value for between group comparisons from generalized estimating equation (GEE) at 6 months. For all p values except for those corresponding to primary and secondary endpoints, p values were adjusted for multiple hypothesis testing in the False Discovery Rate context.
†
Significant difference from baseline within group
NYHA – New York Heart Association, KCCQ – Kansas City Cardiomyopathy Questionnaire, GDS – Geriatric Depression Scale, WOMAC – Western Ontario and McMasters Arthritis Index