Table 4.

Relationship between echocardiography parameters at baseline and the SHIFT primary composite endpoint and its components in the placebo group of the substudy (included set echo)

	Number of events	HR (95% CI)	P-value
LVESVI (n = 263)
SHIFT primary composite endpoint
≥59 mL/m2	56	1.62 (1.03–2.56)	0.04
<59 mL/m2	35
Hospitalization for worsening heart failure
≥59 mL/m2	44	1.80 (1.06–3.07)	0.03
<59 mL/m2	25
Cardiovascular deatha
≥59 mL/m2	28	1.56 (0.78–3.10)	0.21
<59 mL/m2	15
LVEDVI (n = 257)
SHIFT primary composite endpoint
≥85 mL/m2	56	1.75 (1.11–2.75)	0.02
<85 mL/m2	34
Hospitalization for worsening heart failure
≥85 mL/m2	44	1.96 (1.15–3.34)	0.01
<85 mL/m2	24
Cardiovascular death
≥85 mL/m2	28	1.65 (0.84–3.23)	0.14
<85 mL/m2	15
LVEF (n = 257)
SHIFT primary composite endpoint
<31%	50	1.21 (0.78–1.88)	0.40
≥31%	40
Hospitalization for worsening heart failure
<31%	39	1.28 (0.77–2.13)	0.34
≥31%	29
Cardiovascular death
<31%	26	1.29 (0.67–2.51)	0.45
≥31%	17

LVESVI, left ventricular end-systolic volume index; LVEDVI, left ventricular end-diastolic volume index; LVEF, left ventricular ejection fraction; HR, hazard ratio; CI, confidence interval.

^aThere were 43 cardiovascular deaths in the placebo group over the entire duration of the main SHIFT study (Table 4), compared with 36 deaths in the two study arms combined during the 8 months of follow-up of the echocardiography substudy (Figure 1).