Table 3.

Secondary and safety endpoints

	Placebo (n=103)	n†	Sildenafil (n=113)	n†	p value
Clinical rank score, mean*	95.8	94	94.2	95	0.85
Change in 6MWD at 24 weeks, median (IQR), m	15.0 (−26.0, 45.0)	95	5.0 (−37.0, 55.0)	90	0.92
Change in Peak VO2 at 12 weeks, median (IQR), ml/kg/min	0.0 (−1.1, 0.7)	96	0.1 (−1.4, 1.3)	97	0.98
Change in 6MWD at 12 weeks, median (IQR), m	18.0 (−14.5, 48.0)	96	10.0 (−25.0, 36.0)	99	0.13
Components of clinical rank score at 24 weeks
Death‡, no. (%)	0 (0)	103	3 (3)	113	0.25
Hospitalization for CV or renal cause, no. (%)	13 (13)	103	15 (13)	113	0.89
Change in MLHFQ, median (IQR)	−8 (−21, 5)	91	−8 (−19, 0)	91	0.44
Safety endpoints
Adverse events, no. (%)	78 (76)	103	90 (80)	113	0.49
Serious adverse events, no. (%)	16 (16)	103	25 (22)	113	0.22

6MWD, six-minute walk distance; CV, cardiovascular; IQR, interquartile range; MLHFQ, Minnesota Living with Heart Failure Questionnaire; VO2, oxygen consumption

^*A mean value of 95 in each group is expected under the null hypothesis of no treatment effect

^† number of patients in placebo or sildenafil treatment groups with data for the variable

^‡ Site investigator identified causes of death were sudden death (n=1), progressive cardiorenal failure (n=1) and non-cardiovascular (n=1)