Table 3.
Primary endpoint and secondary endpoints of the two groups
| Experimental group (n = 57) | Control group (n = 60) | p Value | |
|---|---|---|---|
| Primary endpoint | |||
| 6MWT at baseline (m) | |||
| Mean ± SD | 214.75 ± 87.84 | 204.62 ± 84.14 | 0.507 |
| Median (Q1, Q3) | 220 (142.50, 280) | 200 (160, 238.75) | |
| Mean difference (95% CI) | 10.14 (−21.36, 41.63) | – | |
| 6MWT at 24-week visit (m) | |||
| Mean ± SD | 292.40 ± 92.15 | 237.16 ± 125.21 | 0.003 |
| Median (Q1, Q3) | 310 (202.50, 357.25) | 200 (165, 291) | |
| Mean difference (95% CI) | 55.24 (12.01, 98.47) | – | |
| Distance difference of the 6MWT (m) | |||
| Mean ± SD | 70.08 ± 85.76 | 27.73 ± 82.00 | <0.001 |
| Median (Q1, Q3) | 60 (31.25, 113.75) | −5 (−20, 68.50) | |
| Mean difference (95% CI) | 46.90 (12.90, 80.90) | – | |
| Adjusted distance difference of the 6MWT (m)a | |||
| Mean difference (95%CI) | 47.40 (11.10, 83.71) | – | 0.011 |
| Secondary endpoints | |||
| MLHFQ score | |||
| Baseline | 45 (32, 59.50) | 47.50 (33.50) | 0.639 |
| 24-week visit | 21 (11, 27)b | 29.50 (8, 54.75)b | 0.128 |
| NT-proBNP (ng/L) | |||
| Baseline | 1,911 (981.25, 5,363.80) | 4,275.90 (1,184, 8,252) | 0.124 |
| 24-week visit | 1,360 (589.80, 3,564)b | 1,654 (774.45, 4,621.50)b | 0.461 |
| EF (%) | |||
| Baseline | 34 (28, 39) | 34.50 (28, 40) | 0.746 |
| 24-week visit | 40 (35.50, 49.50)b | 41 (32, 51.50)b | 0.908 |
| LA (mm) | |||
| Baseline | 46 (41.50, 50) | 46 (41, 51.75) | 0.675 |
| 24-week visit | 42 (38.50, 47.25) | 46 (40.25, 53) | 0.066 |
| LV (mm) | |||
| Baseline | 62 (57, 72) | 63 (57.33, 68) | 0.501 |
| 24-week visit | 56.50 (48, 63.25)b | 56 (50, 65.50) | 0.705 |
| AO (mm) | |||
| Baseline | 32.00 (30.00, 37.00) | 32.00 (27.50, 35.50) | 0.302 |
| 24-week visit | 32.00 (28.00, 36.00) | 32.00 (29.00, 35.00) | 0.572 |
| IVS (mm) | |||
| Baseline | 9.00 (8.00, 11.00) | 9.00 (8.00, 10.00) | 0.148 |
| 24-week visit | 9.00 (8.00, 10.00) | 9.00 (8.00, 10.00) | 0.313 |
| LVPW (mm) | |||
| Baseline | 9.00 (8.00, 10.00) | 9.00 (8.00, 10.00) | 0.884 |
| 24-week visit | 9.00 (8.00, 10.00) | 9.00 (8.00, 10.00) | 0.845 |
6MWT, 6-min walk test; MLHFQ, Minnesota Living with Heart Failure Questionnaire; NT-proBNP, N-terminal pro-B-type natriuretic peptide; EF, ejection fraction; LV, left ventricular; LA, left atrium; AO, aortic diameter; IVS, interventricular septum; LVPW, left ventricular posterior wall.
a
The difference of the 6MWT between the experimental group and control groups was adjusted for baseline age, gender, EF, TSH, and history of hypertension.
b
Intragroup comparison showed statistically significant differences between baseline and 24-week visit. The p value is presented as a non-parametric test result.