BACKGROUND: Depression is relatively common in patients with coronary heart disease (CHD) and is associated with worse prognosis. Recently there has been interest in evaluating the impact of treating depression on clinical outcomes. Anti-depressant medications have been shown to be safe and efficacious for many patients; exercise also may be effective for treating depression and may also improve cardiopulmonary functioning. However, methodological limitations of previous studies have raised questions about the value of exercise, and no study has compared the effects of exercise with standard anti-depressant medication in depressed cardiac patients. PURPOSE: UPBEAT is a randomized clinical trial (RCT) funded by NHLBI to evaluate the effects of sertraline or exercise compared to placebo on depression and biomarkers of cardiovascular risk in patients with CHD and elevated depressive symptoms. METHODS: The UPBEAT study includes 200 stable CHD patients with scores on the Beck Depression Inventory (BDI) > or =9 randomized to 4 months of treatment withaerobic exercise, sertraline, or placebo. The primary outcomes include depressive symptoms determined by clinical ratings on the Hamilton Rating Scale for Depression (HAM-D) and measures of heart rate variability (HRV), baroreflex control (BRC), vascular function (i.e., flow-mediated dilation (FMD)), and measures of inflammation and platelet aggregation. RESULTS: This article reviews the rationale and design of UPBEAT and addresses several key methodologic issues that were carefully considered in the development of this protocol: the use of a placebo control condition in depressed cardiac patients, study design, and selection of intermediate endpoints or biomarkers of cardiovascular risk. LIMITATIONS: This study is not powered to assess treatment group differences in CHD morbidity and mortality. Intermediate endpoints are not equivalent to 'hard' clinical events and further studies are needed to determine the clinical significance of these biomarkers. CONCLUSIONS: The UPBEAT study is designed to assess the efficacy of exercise in treating depression in cardiac patients and evaluates the impact of treating depression on important biomarkers of cardiovascular risk.
RCT Entities:
BACKGROUND:Depression is relatively common in patients with coronary heart disease (CHD) and is associated with worse prognosis. Recently there has been interest in evaluating the impact of treating depression on clinical outcomes. Anti-depressant medications have been shown to be safe and efficacious for many patients; exercise also may be effective for treating depression and may also improve cardiopulmonary functioning. However, methodological limitations of previous studies have raised questions about the value of exercise, and no study has compared the effects of exercise with standard anti-depressant medication in depressed cardiacpatients. PURPOSE: UPBEAT is a randomized clinical trial (RCT) funded by NHLBI to evaluate the effects of sertraline or exercise compared to placebo on depression and biomarkers of cardiovascular risk in patients with CHD and elevated depressive symptoms. METHODS: The UPBEAT study includes 200 stable CHD patients with scores on the Beck Depression Inventory (BDI) > or =9 randomized to 4 months of treatment with aerobic exercise, sertraline, or placebo. The primary outcomes include depressive symptoms determined by clinical ratings on the Hamilton Rating Scale for Depression (HAM-D) and measures of heart rate variability (HRV), baroreflex control (BRC), vascular function (i.e., flow-mediated dilation (FMD)), and measures of inflammation and platelet aggregation. RESULTS: This article reviews the rationale and design of UPBEAT and addresses several key methodologic issues that were carefully considered in the development of this protocol: the use of a placebo control condition in depressed cardiacpatients, study design, and selection of intermediate endpoints or biomarkers of cardiovascular risk. LIMITATIONS: This study is not powered to assess treatment group differences in CHD morbidity and mortality. Intermediate endpoints are not equivalent to 'hard' clinical events and further studies are needed to determine the clinical significance of these biomarkers. CONCLUSIONS: The UPBEAT study is designed to assess the efficacy of exercise in treating depression in cardiacpatients and evaluates the impact of treating depression on important biomarkers of cardiovascular risk.
Authors: Robert M Carney; James A Blumenthal; Kenneth E Freedland; Marston Youngblood; Richard C Veith; Matthew M Burg; Carol Cornell; Patrice G Saab; Peter G Kaufmann; Susan M Czajkowski; Allan S Jaffe Journal: Psychosom Med Date: 2004 Jul-Aug Impact factor: 4.312
Authors: Heather S Lett; James A Blumenthal; Michael A Babyak; Andrew Sherwood; Timothy Strauman; Clive Robins; Mark F Newman Journal: Psychosom Med Date: 2004 May-Jun Impact factor: 4.312
Authors: Rebecca A Gary; Sandra B Dunbar; Melinda K Higgins; Dominique L Musselman; Andrew L Smith Journal: J Psychosom Res Date: 2010-03-12 Impact factor: 3.006
Authors: Balraj S Heran; Jenny Mh Chen; Shah Ebrahim; Tiffany Moxham; Neil Oldridge; Karen Rees; David R Thompson; Rod S Taylor Journal: Cochrane Database Syst Rev Date: 2011-07-06
Authors: Petra W Hoen; Mary A Whooley; Elisabeth J Martens; Beeya Na; Joost P van Melle; Peter de Jonge Journal: J Am Coll Cardiol Date: 2010-09-07 Impact factor: 24.094
Authors: Matthew P Harbaugh; Stephen B Manuck; J Richard Jennings; Sarah M Conklin; Jeffrey K Yao; Matthew F Muldoon Journal: Int J Cardiol Date: 2012-06-16 Impact factor: 4.164
Authors: James A Blumenthal; Silvina Waldman; Michael A Babyak; Andrew Sherwood; Michael Sketch; Lana L Watkins Journal: Am Heart J Date: 2009-05-01 Impact factor: 4.749
Authors: Mary A Whooley; Peter de Jonge; Eric Vittinghoff; Christian Otte; Rudolf Moos; Robert M Carney; Sadia Ali; Sunaina Dowray; Beeya Na; Mitchell D Feldman; Nelson B Schiller; Warren S Browner Journal: JAMA Date: 2008-11-26 Impact factor: 56.272