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 .
The effect of digoxin on the quality of life in patients with heart failure.
BACKGROUND The Digitalis Investigation Group ( DIG ) trial was a r and omized double-blind placebo-controlled study that examined the effect of digoxin on mortality in 7,788 patients with heart failure and sinus rhythm . A prespecified sub study evaluated the effect of digoxin therapy on health-related quality of life ( HQOL ) in a subset of these patients . METHODS Patients in the DIG trial had clinical heart failure and were r and omized to either digoxin or placebo in addition to their baseline diuretic and angiotensin-converting enzyme therapy ( n = 7,788 ) . The patients in this sub study had HQOL measured using a self-administered question naire employing scales that measured general health , physical functioning , depression , anger , anxiety , life satisfaction , and disease specific measures . A subjective assessment by the investigator and a 6-minute walk test evaluated functional status . HQOL was measured at baseline and at the 4- and 12-month follow-up visits . RESULTS The baseline characteristics of the patients in the quality of life sub study ( n = 589 ) were comparable to the remaining patients in the study ( n = 7,199 ) by age and other clinical measures , including history of prior myocardial infa rct ion or etiology of heart failure ; heart failure was of shorter duration and the ejection fraction was slightly better than in the main trial . Within the sub study , patients receiving digoxin ( n = 298 ) or  placebo ( n = 291 ) were also similar in baseline characteristics . There was no statistically significant difference in any HQOL measure between the digoxin and the placebo groups at baseline . At the 4-month visit , only perceived health was improved in the digoxin group . At 12 months , there was no statistically significant difference in perceived health , physical functioning , Minnesota Living with Heart Failure , depression , anxiety , anger , Ladder of Life , or the 6-minute walk between the digoxin and placebo groups . CONCLUSION In this subset of the DIG population , digoxin therapy had no effect on the HQOL in patients with heart failure in sinus rhythm
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 .