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 (SSRI), 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 co-morbid major depressive disorder (MDD) is unknown. Method 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 HF patients. Approximately 500 men and women who are ≥45 years of age with current MDD and chronic systolic HF, characterized by left ventricular ejection fraction (LVEF) ≤45% and New York Heart Association (NYHA) class ≥ 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. Conclusion Because of the high prevalence of depression and its significant adverse impact on prognosis of patients with ischemic heart disease and HF, the 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.

Prognosis in Heart Failure and the Value of β-Blockers Are Altered by the Use of Antidepressants and Depend on the Type of Antidepressants Used

“…Currently, several trials are testing the efficacy of antidepressive intervention on outcome in various groups of patients with cardiac disease. [21][22][23] Current guidelines on the pharmacological approach to treating depression in patients with cardiac disease state that, although data are lacking, it is recommended that SSRIs are chosen before TCAs. 25 This is, however, not based on data but on the known adverse event profiles or efficacy relation in depression without cardiac disease and the problems with the proarrhythmic risk associated with the TCAs.…”

“…[21][22][23] The importance of antidepressant therapy in a large real-life population of patients with HF has not been investigated. However, 1 clinical trial has suggested a beneficial effect of antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) agent but only in patients having a substantial reduc-tion of depressive symptoms.…”

JAKOŚĆ W MEDYCYNIE Depression in chronic heart failure

“…Even in long-term follow-up, the use of these drugs was associated with only a small percentage of adverse effects and drug interactions [33]. According to the results of the SADHART-CHF trial (Safety and Efficacy of Sertraline for Depression in Patients with CHF), sertraline (an SSRI drug) can be safely used in HF patients [34]. The CREATE study (Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy) confirms the efficacy and safety of citalopram (SSRI) in the treatment of depression in patients with cardiovascular diseases [35].…”

Mind-Body Medicine in Chronic Heart Failure

“…140 • Evaluate the capacity of mind-heart interventions to improve ventricular function through interruption of the cascade of autonomic and proinflammatory pathways activated by depression and stress. 141,142 • Investigate the response to mind-body interventions in the context of different genetic backgrounds similar to the pharmacogenetic impact on drug response. Conversely, evaluate the impact of mind-heart interventions on gene function based on preliminary studies showing the plausibility of "mind/gene" interactions.…”