The National Institute of Mental Health (NIMH) has awarded researchers at the University of Pittsburgh School of Medicine a three-year, $500,000 grant to develop a novel intervention strategy for simultaneously treating congestive heart failure and major depression.
The study is designed to obtain the necessary feasibility and clinical data required to plan a large-scale trial, which will compare the impact of a ?blended? depression/heart failure care management programs vs. traditional heart failure care management program on cardiovascular morbidity and mortality, health-related quality of life, mood symptoms, health care costs and a variety of other outcomes of interest.
Heart failure affects 5 million Americans, with more than 550,000 newly diagnosed cases, 287,000 deaths and $30 billion in both direct and indirect costs each year. It also is the leading cause for hospitalization, and its five-year mortality rate following first hospital admission for heart failure exceeds that of most cancers.
Depression is present in approximately 20 to 50 percent of heart failure patients and compelling evidence links it to increased morbidity and mortality and reduced quality of life. Yet, although the University of Pittsburgh Medical Center (UPMC) and several other integrated health care delivery systems across the United States have implemented outpatient care management programs for heart failure, none routinely screen for and treat depression.
The study of the connections between mental health and cardiovascular disease is not new to the study?s principal investigator, Bruce L. Rollman, M.D., M.P.H., associate professor of medicine and psychiatry, University of Pittsburgh School of Medicine. Since 2004, he and his co-principal study investigator, Charles F. Reynolds III, M.D., UPMC Professor of Geriatric Psychiatry, University of Pittsburgh School of Medicine, and their research team have been recruiting patients from several Pittsburgh-area hospitals, including UPMC Presbyterian and UPMC Passavant, into the first NIH-funded clinical trial titled, ?Bypassing the Blues,? designed to examine the impact of treating depressive symptoms following coronary artery bypass graft (CABG) surgery.
In this latest study, Drs. Rollman and Reynolds, with the help of their co-investigators Dennis McNamara, M.D., professor of medicine and director of UPMC Heart Failure Transplantation, and Rene Alvarez, M.D., associate professor of medicine and director of UPMC Heart Failure/Pulmonary Hypertension Network, will modify their ?Bypassing the Blues? protocol for treating post-CABG depression. They will employ the UPMC outpatient guidelines for treating heart failure and then pilot their ?blended? treatment strategy for treating depressed heart failure patients. They will recruit approximately 500 patients admitted for an acute episode of heart failure from UPMC Presbyterian, UPMC St. Margaret, UPMC Braddock and UPMC McKeesport hospitals, and then conduct follow-up telephone assessments at one, three and six months to estimate suitably sensitive and specific cut-off scores for treating depression by gender and severity of heart failure.
?The subject of depression and congestive heart failure has received little attention until recently. We need to look at these two conditions differently than in the past, as depression is seldom diagnosed and often untreated in patients with congestive heart failure,? commented Dr. Rollman. ?We also hope to learn through the cohort study how to better determine the severity of depressive symptoms that merit further attention from heart failure specialists.?
?Cardiologists can help their patients if they are provided with the knowledge of depression?s devastating effects on heart disease. Early studies have demonstrated that if patients are treated for depression after heart surgery or any invasive heart procedure, they are more likely to stick to their scheduled treatments and have a better, more positive outlook toward recovery,? says Dr. McNamara.
?Depression is a complex disease with many symptoms similar to heart failure. If we can develop a better clinical model in recognizing and detecting depression, we hope to be able to gather enough data to support the need for a large-scale trial to test the effectiveness of a combined depression and heart failure treatment over the current standard of care for heart failure which does not address depression,? added Dr. Reynolds.