New Hope for the Sad Heart: SADHART Clinical Trial Presents Evidence of How Treatment Can Improve Depression and Morbidity in Heart Failure

Study demonstrates new SSRI drug Sertraline which interacts favorably in patients suffering from depression and heart failure

TORONTO, September 22, 2008 /PRNewswire-USNewswire/ -- "Safety and Efficacy of Sertraline for Depression in Patients with CHF: SADHART-CHF Trial," a clinical trial in heart failure, was presented today by Dr. Christopher O'Connor (Professor of Medicine and Director, Duke Heart Center, ) in the Late Breaking Clinical Trial session at the 12th Annual Scientific Meeting of the Heart Failure Society of America (HFSA). This clinical trial highlighted the results of treating patients who suffer from heart failure and depression with the drug Sertraline, which is a selective serotonin-reuptake inhibitor (SSRI) anti-depressant with psycho-supportive therapy. It was used to evaluate the effectiveness in improving mood disorders, and the results also showed a decrease in mortality with heart failure patients.

"For years, the only anti-depressive treatments were in the form of tricyclics, which were associated with instances of sudden death and arrhythmias in patients being treated for both chronic heart failure and mood disorders," said Dr. Barry Greenberg, HFSA President, and Professor of Medicine, and Director, Advanced Heart Failure Treatment Program, . "Finding a safe and effective means to treat depression and lower the fatality rates in heart failure patients would mark a major advancement for the medical community, and bring relief and a renewed hope for cardiology patients."

Dr. O'Connor explained that the trial was designed to test the hypothesis that heart failure patients treated with Sertraline plus psycho-supportive therapy will have an improvement in symptoms of depression and a lower rate of mortality and cardiovascular events as compared to psycho-supportive therapy alone. This larger trial was in response to a similar trial which had showed promising results that Sertraline not only proved to be safe and effective, but tended to reduce morbidity and mortality and improve depression in heart failure patients. This larger trial SADHART was a randomized, double-blind, placebo-controlled study that investigated the use of Sertraline as an effective way to treat patients who presented as having a major depressive disorder (MDD) and a diagnosis of heart failure. The trial, sponsored by the National Institute of Mental Health, studied a population of 500 men and women 45 years of age or older who were randomized to Sertraline or placebo group for a 12-week acute treatment phase. All patients were followed for six months. Quality of life and physiologic parameters, as well as pro-inflammatory and HF biomarkers were also obtained.

"Sertraline has a very favorable pharmacological profile, in terms of adverse reactions with other drugs, which is crucial because heart failure patients often take up to 12 different medications. Our study aims to test whether depression, which has been an ongoing topic of research since the 1920s, can be greatly reduced through the use of SSRI's like Sertraline or by psycho-supportive therapy," said Dr. O'Connor, who added that patients with heart failure and depression are twice as likely to die from cardiac complications than patients who suffer from heart failure. "We hope that this presentation demonstrates the importance of identifying and treating depression in heart failure patients must continually be examined. We hope to soon conduct similar trials to SADHART, but with a long-term period of follow-up in similar study populations."

For a complete list of annual meeting sessions or for details on attending the conference, call (617) 226-7198 or visit www.hfsa.org and click on Annual Scientific Meeting. There is no registration fee for accredited journalists. Interview areas will be available on-site in addition to a fully-staffed press room with phone and internet accessibility.

About Heart Failure

Heart failure is a progressive condition in which the heart muscle becomes weakened after it is injured from heart attack or high blood pressure and gradually loses its ability to pump enough blood to supply the body's needs. Many people are not aware they have heart failure because the symptoms are often mistaken for signs of getting older. Heart failure affects from 4.6 to 4.8 million individuals in the United States. Demographic and clinical evidence strongly suggest the prevalence of heart failure will increase throughout the next decade. Ten to 15 years ago heart failure was considered a "death sentence;" however, recent advances in treatment have shown that early diagnosis and proper care in early stages of the condition are key to slowing, stopping or in some cases reversing progression, improving quality of life, and extending life expectancy. For more information on heart failure, please visit www.abouthf.org.

About the Heart Failure Society of America

The Heart Failure Society of America (HFSA) is a nonprofit educational organization, founded in 1994 as the first organized association of heart failure experts. Today HFSA has over 1,700 members and provides a forum for all those interested in heart function, heart failure research and patient care. The Society also serves as a resource for governmental agencies (FDA, NIH, NHLBI, CMS). The HFSA Annual Scientific Meeting is designed to highlight recent advances in the development of strategies to address the complex epidemiological, clinical and therapeutic issues of heart failure. Additional information on HFSA can be found at www.hfsa.org.

CONTACT: Kaitlyn Siner, +1-617-226-7192, cell, +1-401-339-0954,, or Ben Hendricks, +1-617-226-7183, cell,+1-919-522-2978, , both for Heart FailureSociety of America ksiner@bellpottingerusa.com bhendricks@bellpottingerusa.com

Web site: http://www.hfsa.org/http://www.abouthf.org/

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Posted: September 2008

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