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 .
Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure. The PRECISE Trial. Prospective Randomized Evaluation of Carvedilol on Symptoms and Exercise.
BACKGROUND Carvedilol has improved the symptomatic status of patients with moderate to severe heart failure in single-center studies , but its clinical effects have not been evaluated in large , multicenter trials . METHODS AND RESULTS We enrolled 278 patients with moderate to severe heart failure ( 6-minute walk distance , 150 to 450 m ) and a left ventricular ejection fraction < or = 0.35 at 31 centers . After an open-label , run-in period , each patient was r and omly assigned ( double-blind ) to either placebo ( n = 145 ) or carvedilol ( n = 133 ; target dose , 25 to 50 mg BID ) for 6 months , while background therapy with digoxin , diuretics , and an ACE inhibitor remained constant . Compared with placebo , patients in the carvedilol group had a greater frequency of symptomatic improvement and lower risk of clinical deterioration , as evaluated by changes in the NYHA functional class ( P = .014 ) or by a global assessment of progress judged either by the patient ( P = .002 ) or by the physician ( P < .001 ) . In addition , treatment with carvedilol was associated with a significant increase in ejection fraction ( P < .001 ) and a significant decrease in the combined risk of morbidity and mortality ( P = .029 ) . In contrast , carvedilol therapy had little effect on indirect measures of patient benefit , including changes in exercise tolerance or quality -of-life scores . The effects of the drug were similar in patients with ischemic heart disease or idiopathic dilated cardiomyopathy as the cause of heart failure . CONCLUSIONS These findings indicate that , in addition to its favorable effects on survival , carvedilol produces important clinical benefits in patients with moderate to severe heart failure treated with digoxin , diuretics , and an ACE inhibitor
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 .