title: Safety and efficacy of sertraline for depression in patients with CHF (SADHART-CHF): a randomized, double-blind, placebo-controlled trial of sertraline for major depression with congestive heart failure.
abstract: BACKGROUND
  Sertraline, a selective serotonin-reuptake inhibitor, has demonstrated substantial mood improvement in patients with post myocardial infarction or with unstable angina. The impact of sertraline on the prognosis and depression of patients with chronic heart failure (HF) and comorbid major depressive disorder (MDD) is unknown.
  
  
  METHODS
  This is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of sertraline in the treatment of MDD in patients with HF. The study is designed also to examine the effects of treating depression on cardiac events and morbidity/mortality in patients with HF. Approximately 500 men and women who are >or=45 years of age with current MDD and chronic systolic HF, characterized by left ventricular ejection fraction <or=45% and New York Heart Association class >or=II, comprise the study population. Eligible participants are randomized to either sertraline or placebo for a 12-week acute treatment phase. All patients, regardless of acute treatment phase completion, are followed routinely until the last subject completes 6-month follow-up. Quality of life and certain physiologic parameters, as well as pro-inflammatory and HF biomarkers, that may reflect the impact of sertraline in this particular population are measured at baseline and at the end of the acute treatment phase.
  
  
  CONCLUSIONS
  Because of the high prevalence of depression and its significant adverse impact on prognosis of patients with ischemic heart disease (IHD) and HF, the Safety and Efficacy of Sertraline for Depression in Patients with Chronic Heart Failure (SADHART-CHF) trial aims to assess the effects of sertraline on response of depression as well as on the cardiac prognosis of patients with HF.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA. jiang001@mc.duke.edu
authors.forename: Wei
authors.initials: W
authors.lastname: Jiang
authors.forename: Christopher
authors.initials: C
authors.lastname: O'Connor
authors.forename: Susan G
authors.initials: SG
authors.lastname: Silva
authors.forename: Maragatha
authors.initials: M
authors.lastname: Kuchibhatla
authors.forename: Michael S
authors.initials: MS
authors.lastname: Cuffe
authors.forename: Dwayne D
authors.initials: DD
authors.lastname: Callwood
authors.forename: Bosh
authors.initials: B
authors.lastname: Zakhary
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Henke
authors.forename: Rebekka M
authors.initials: RM
authors.lastname: Arias
authors.forename: Ranga
authors.initials: R
authors.lastname: Krishnan