Heart failure has been called the most important public health problem facing cardiovascular clinicians and researchers because of its high and increasing incidence, prevalence, morbidity and mortality. Despite substantial advances in pharmacologic therapy made in recent years, clinical improvements seen among patients are relatively modest and quality of life often remains poor. Nonpharmacologic therapy has received relatively little attention, yet has potential to serve as an important adjunct to pharmacologic therapy. Biofeedback-relaxation, a cognitive biobehavioral nonpharmacologic intervention, has been demonstrated to be effective in conditions with pathophysiological and psychological manifestations of heart failure. Accordingly, specific aims of this project are to determine the impact of biofeedback-relaxation training on 1) the combined primary end-point of heart failure rehospitalizations or cardiac mortality, 2) quality of life; 3) intermediate (mediating) patient outcomes of perceived control, anxiety and depression, and 4) intermediate (mediating) physiologic outcomes of finger and foot skin temperature, heart rate variability and plasma norepinephrine. We hypothesize that biofeedback-relaxation training will result in decreased heart failure rehospitalizations or cardiac death, improved quality of life, increased perceived control, decreased anxiety and depression, increased finger and foot temperature, improved heart rate variability, and decreased plasma norepinephrine. To test these hypotheses, 420 patients with advanced heart failure will be randomized to one of three groups: 1) biofeedback-relaxation (intervention); 2) sham biofeedback-relaxation (placebo-control); or 3) usual care control. Within these groups, patients will be stratified such that each group will include 50% taking and 50% not taking angiotensin converting enzyme inhibitors. Data will be collected at baseline, 3, and 12 months and will be analyzed using survival analyses and repeated measure ANOVA. Biofeedback-relaxation training for patients with heart failure may have potential long-term clinical benefits and may serve as an important adjunct to pharmacologic therapy. ? ?
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