Table 3.
Echocardiographic parameters at baseline, 8 months, and their changes in the substudy
| Variable | Ivabradine |
Placebo |
Treatment effect |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| n | Baseline | 8 months | Change | n | Baseline | 8 months | Change | E (SE), 95% CI | P-value | |
| Primary endpoint | ||||||||||
| LVESVI (mL/m2) | 208 | 65.2 ± 29.1 | 58.2 ± 28.3 | −7.0 ± 16.3 | 203 | 63.6 ± 30.1 | 62.8 ± 28.7 | −0.9 ± 17.1 | −5.8 (1.6), −8.8 to −2.7 | <0.001 |
| Secondary endpoints | ||||||||||
| LVESV (mL) | 208 | 123.8 ± 55.6 | 110.8 ± 54.6 | −13.0 ± 31.6 | 203 | 122.2 ± 59.8 | 120.9 ± 56.4 | −1.3 ± 32.8 | −11.2 (3.0), −17.1 to −5.4 | <0.001 |
| LVEDVI (mL/m2) | 204 | 93.9 ± 32.8 | 85.9 ± 30.9 | −7.9 ± 18.9 | 199 | 90.8 ± 33.1 | 89.0 ± 31.6 | −1.8 ± 19.0 | −5.5 (1.8), −8.9 to −2.0 | 0.002 |
| LVEDV (mL) | 204 | 178.4 ± 63.4 | 163.7 ± 60.6 | −14.7± 36.4 | 199 | 174.7 ± 67.6 | 171.7 ± 63.8 | −2.9 ± 36.8 | −10.9 (3.4), −17.6 to −4.2 | 0.001 |
| LVEF (%) | 204 | 32.3 ± 9.1 | 34.7 ± 10.2 | 2.4 ± 7.7 | 199 | 31.6 ± 9.3 | 31.5 ± 10.0 | −0.1 ± 8.0 | 2.7 (0.8), 1.3 to 4.2 | <0.001 |
Data are numbers of patients (%) or means ± SD. Parametric approach with adjustment for country, beta-blocker intake at randomization, and baseline value. E (SE), estimate (standard error of treatment effect); CI, confidence interval.
LVESV, left ventricular end-systolic volume; LVESVI, left ventricular end-systolic volume index; LVEDV, left ventricular end-diastolic volume; LVEDVI, left ventricular end-diastolic volume index; LVEF, left ventricular ejection fraction.