BACKGROUND: Depression is a common comorbidity in heart failure and is strongly associated with increased mortality, morbidity, and reduced health status. Whether depression treatment may result in improvement of health status in heart failure patients with comorbid depression remains unknown. METHODS AND RESULTS: The Sertraline Against Depression and Heart Disease in Chronic Heart Failure study randomized 469 participants with chronic heart failure (left ventricular ejection fraction 45% and New York Heart Association class II) and major depressive disorder based on Diagnostic Statistics Manual fourth edition criteria tosertraline or placebofor 12 weeks. The Kansas City Cardiomyopathy Questionnaire, 36-Item Short-Form Health Survey, and 6-minute walk test were used to assess health status. Health status changes between treatment arms and remission status were evaluated adjusting for baseline variables and treatment assignment. The final Hamilton Depression Rating Scale scores were 3.50±2.08 and 12.97±4.33 in the remission and nonremission groups, respectively (P value=0.0001). Of 469 total participants, 378 (80.6%) completed the 6-minute walk test and 285 (70.1%) completedKansas city cardiomyopathy questionnaire and 36-item short-form health survey, at baseline and at week 12. Depression remission was significantly associated with higher improvements in Kansas City Cardiomyopathy Questionnaire subscale scores (P<0.001) except on the Self-Efficacy (P=0.18) and Symptom Stability (P=0.91). On the 36-Item Short-Form Health Survey, depression remission was associated with significant improvement in subscales of the physical and mental component summary except the Pain Index (P=0.34). The 6-minute walk test improved more in depression remission compared with nonremission group (difference from baseline: 63.51±238.78 versus 16.24±115.70 m, P=0.03). CONCLUSIONS: Patients with heart failure whose depressive symptoms remitted had significantly greater improvement in physical function, social function, and quality of life.
RCT Entities:
BACKGROUND:Depression is a common comorbidity in heart failure and is strongly associated with increased mortality, morbidity, and reduced health status. Whether depression treatment may result in improvement of health status in heart failurepatients with comorbid depression remains unknown. METHODS AND RESULTS: The Sertraline Against Depression and Heart Disease in Chronic Heart Failure study randomized 469 participants with chronic heart failure (left ventricular ejection fraction 45% and New York Heart Association class II) and major depressive disorder based on Diagnostic Statistics Manual fourth edition criteria to sertraline or placebo for 12 weeks. The Kansas City Cardiomyopathy Questionnaire, 36-Item Short-Form Health Survey, and 6-minute walk test were used to assess health status. Health status changes between treatment arms and remission status were evaluated adjusting for baseline variables and treatment assignment. The final Hamilton Depression Rating Scale scores were 3.50±2.08 and 12.97±4.33 in the remission and nonremission groups, respectively (P value=0.0001). Of 469 total participants, 378 (80.6%) completed the 6-minute walk test and 285 (70.1%) completed Kansas city cardiomyopathy questionnaire and 36-item short-form health survey, at baseline and at week 12. Depression remission was significantly associated with higher improvements in Kansas City Cardiomyopathy Questionnaire subscale scores (P<0.001) except on the Self-Efficacy (P=0.18) and Symptom Stability (P=0.91). On the 36-Item Short-Form Health Survey, depression remission was associated with significant improvement in subscales of the physical and mental component summary except the Pain Index (P=0.34). The 6-minute walk test improved more in depression remission compared with nonremission group (difference from baseline: 63.51±238.78 versus 16.24±115.70 m, P=0.03). CONCLUSIONS:Patients with heart failure whose depressive symptoms remitted had significantly greater improvement in physical function, social function, and quality of life.
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