Pharmacological trials including patients with more severe heart failure were more likely to show a significant improvement with therapy than trials of milder heart failure .
Using mean values in these trials , the age of patients appeared a more important determinant of 6MWT distance than New York Heart Association classification .
The 6MWT has not yet been proven to be a robust test for the identification of effective pharmacological interventions although it appears useful for the assessment of cardiac resynchronization therapy .
The results of the 6MWT were concordant with changes in symptoms , suggesting that it may be used as supportive evidence for symptom benefit .
AIMS The 6 min walk test ( 6MWT ) is commonly used in clinical trials to assess treatments for heart failure , but its ability to distinguish between effective and ineffective treatments is question able .
The aim of this study is to investigate , using a systematic literature review , the utility of the 6MWT as a measure of the effectiveness of treatment in r and omized controlled trials of heart failure .
Effects of amlodipine on exercise tolerance, quality of life, and left ventricular function in patients with heart failure from left ventricular systolic dysfunction.
BACKGROUND A preliminary study suggested that the long-acting late-generation calcium-channel blocker amlodipine has favorable effects on exercise tolerance and is safe to use in heart failure , in contrast to earlier generation agents . The goal of 2 multicenter studies was to assess the effect of adjunctive therapy with amlodipine in addition to st and ard therapy on exercise capacity , quality of life , left ventricular function , and safety parameters in patients with heart failure and left ventricular systolic dysfunction . METHODS Two large multicenter trials examining the effects of amlodipine on these parameters over a 12-week period of therapy were undertaken in patients with mild to moderate heart failure and left ventricular systolic dysfunction . A total of 437 patients with stable heart failure were studied in a r and omized , double-blind , placebo-controlled prospect i ve design . RESULTS Amlodipine at a dose of 10 mg/day in addition to st and ard therapy in such patients was associated with no significant difference in change in exercise tolerance on a Naughton protocol compared with placebo in each trial . Among all patients taking amlodipine , exercise time increased 53 + /- 9 ( SE ) seconds ; exercise time for those taking placebo increased 66 + /- 9 seconds ( P = not significant ) . There were no significant differences in changes of quality of life parameters between amlodipine- and placebo-treated patients , and there were no significant differences in symptom scores or New York Heart Association classification between groups . Left ventricular function ( measured as ejection fraction ) improved 3 . 4 % + /- 0.5 % in amlodipine-treated patients and 1.5 % + /- 0.5 % in placebo-treated patients ( P = .007 ) . There was no statistically significant excess of important adverse events ( episodes of worsening heart failure in 10 % amlodipine-treated vs 6.3 % of placebo-treated patients ) or differences in need for changes in background medication between groups . CONCLUSIONS The addition of 10 mg of amlodipine per day to st and ard therapy in patients with heart failure is associated with no significant improvement in exercise time compared with placebo therapy over a 12-week period , and there was no increased incidence of adverse events . These data suggest that the addition of amlodipine to st and ard therapy in heart failure will not result in additional efficacy per se beyond st and ard therapy
Pharmacological trials including patients with more severe heart failure were more likely to show a significant improvement with therapy than trials of milder heart failure .
Using mean values in these trials , the age of patients appeared a more important determinant of 6MWT distance than New York Heart Association classification .
The 6MWT has not yet been proven to be a robust test for the identification of effective pharmacological interventions although it appears useful for the assessment of cardiac resynchronization therapy .
The results of the 6MWT were concordant with changes in symptoms , suggesting that it may be used as supportive evidence for symptom benefit .
AIMS The 6 min walk test ( 6MWT ) is commonly used in clinical trials to assess treatments for heart failure , but its ability to distinguish between effective and ineffective treatments is question able .
The aim of this study is to investigate , using a systematic literature review , the utility of the 6MWT as a measure of the effectiveness of treatment in r and omized controlled trials of heart failure .