57688
document
Is chronic sildenafil therapy safe and clinically beneficial in patients with systolic heart failure ? Sildenafil is a selective phosphodiesterase-5 inhibitor and causes vasodilatation , particularly in pulmonary circulation . Since left heart failure may be associated with pulmonary hypertension " out of proportion to left heart disease , " sildenafil may have beneficial effect in such patients . The present investigation was designed as a 12-week , single-center , randomized , double-blind , placebo-controlled study evaluating the effects of sildenafil on mean blood pressure ( primary endpoint ) in patients with left systolic heart failure . Secondary endpoints included exercise capacity assessed by 6-minute walk test . A total of 106 patients were randomized 1:1 to sildenafil ( n=53 ) or placebo ( n=53 ) . Patients received sildenafil 25 mg twice a day or matching placebo for the first 2 weeks and 50 mg 3 times a week for the remainder of the trial . The placebo-corrected effect on mean blood pressure was 1.16 mm Hg ( 95 % confidence interval , -1.6 to 5.1 , P > .05 ) , demonstrating that sildenafil did not decrease mean blood pressure . Compared with placebo , sildenafil increased the 6-minute walk test by a nonsignificant treatment effect of 14 m ( P=.67 ) . Adverse effects occurred in a comparable proportion of patients taking sildenafil and placebo , and none of the patients needed to discontinue therapy . Sildenafil is well tolerated in left heart failure patients and does not decrease blood pressure . It can be safely added to standard heart failure therapy .
57689
Intervention_Pharmacological
chronic sildenafil therapy
57690
Intervention_Pharmacological
Sildenafil
57691
Intervention_Pharmacological
sildenafil
57692
Intervention_Control
placebo-controlled
57693
Intervention_Pharmacological
sildenafil
57694
Intervention_Pharmacological
sildenafil
57695
Intervention_Control
placebo
57696
Intervention_Pharmacological
sildenafil
57697
Intervention_Control
placebo
57698
Intervention_Pharmacological
sildenafil
57699
Intervention_Pharmacological
sildenafil
57700
Outcome_Physical
mean blood pressure
57701
Outcome_Physical
exercise capacity
57702
Outcome_Physical
6-minute walk test .
57703
Outcome_Physical
mean blood pressure
57704
Outcome_Physical
mean blood pressure .
57705
Outcome_Physical
6-minute walk test
57706
Outcome_Adverse-effects
Adverse effects
57707
Outcome_Other
tolerated
57708
Outcome_Physical
blood pressure .
57709
Participant_Condition
systolic heart failure
57710
Participant_Condition
left heart failure
57711
Participant_Condition
left systolic heart failure
57712
Participant_Sample-size
106
57713
Participant_Sample-size
n=53
57714
Participant_Sample-size
n=53