Clinical Research
Clinical Trial
Safety and Efficacy of Sertraline for Depression in Patients With Heart Failure: Results of the SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) Trial

https://doi.org/10.1016/j.jacc.2010.03.068Get rights and content
Under an Elsevier user license
open archive

Objectives

The objective was to test the hypothesis that heart failure (HF) patients treated with sertraline will have lower depression scores and fewer cardiovascular events compared with placebo.

Background

Depression is common among HF patients. It is associated with increased hospitalization and mortality.

Methods

The SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial was a randomized, double-blind, placebo-controlled trial of sertraline 50 to 200 mg/day versus matching placebo for 12 weeks. All participants also received nurse-facilitated support. Eligible patients were age 45 years or older with HF (left ventricular ejection fraction ≤45%, New York Heart Association functional class II to IV) and clinical depression (Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria for current major depressive disorder). Those with significant cognitive impairment, psychosis, recent alcohol or drug dependence, bipolar or severe personality disorder, active suicidal ideation, and current antipsychotic or antidepressant medications were excluded. Primary end points were change in depression severity (Hamilton Depression Rating Scale total score) and composite cardiovascular status at 12 weeks.

Results

A total of 469 patients were randomized (n = 234 sertraline, n = 235 placebo). The mean ± SE change from baseline to 12 weeks in the Hamilton Depression Rating Scale total score was −7.1 ± 0.5 (sertraline) and −6.8 ± 0.5 (placebo) (p < 0.001 from baseline, p = 0.89 between groups, mean change between groups −0.4; 95% confidence interval: −1.7 to 0.92). The proportions whose composite cardiovascular score worsened, improved, or was unchanged were 29.9%, 40.6%, and 29.5%, respectively, in the sertraline group and 31.1%, 43.8%, and 25.1%, respectively, in the placebo group (p = 0.78).

Conclusions

Sertraline was safe in patients with significant HF. However, treatment with sertraline compared with placebo did not provide greater reduction in depression or improved cardiovascular status among patients with HF and depression. (Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure [SADHART-CHF]; NCT00078286)

Key Words

depression
heart failure

Abbreviations and Acronyms

HDRS
Hamilton Depression Rating Scale
HF
heart failure
NYHA
New York Heart Association
SSRI
selective serotonin reuptake inhibitor

Cited by (0)

The SADHART-CHF study was funded by the National Institute of Mental Health(NIMH), Bethesda, Maryland. Sertraline was supplied by Pfizer, Inc., New York, New York. Pfizer had no other role in any aspect of the study. Dr. O'Connor has received grants or research funding from Pfizer, Inc.and received salary support through the NIMHresearch grant. Dr. Jiang received salary support through the NIMHresearch grant and has received funding from Pfizer, Inc.to study nonpharmacologic intervention in depression improvement and the effects of pregabalin on the autonomic nervous system of patients with diabetes. Dr. Kuchibhatla has received salary support through an NIMHresearch grant. Dr. Silva receives honoraria from Pfizer, Inc.related to work as a Data Safety Monitoring Board member, providing Data Safety Monitoring Board oversight of 4 pediatric mental health trials that do not involve sertraline, the medication studied in SADHART-CHF. He also received salary support through the NIMHresearch grant. Dr. Cuffe is a consultant to Novartis and GlaxoSmithKline and receives honoraria from Novartis and GlaxoSmithKline. He also received salary support through the NIMHresearch grant. Dr. Callwood (Callwood Cardiology) received salary support through the NIMHresearch grant. Drs. Zakhary and Stough report that they have no relationships to disclose. Ms. Arias received salary support through the NIMHresearch grant. Dr. Rivelli received salary support through the NIMHresearch grant. Dr. Krishnan is a consultant to Amgen, Bristol-Myers Squibb, CeNeRx, Corcept, GlaxoSmithKline, Johnson & Johnson, Lundbeck, Merck, Organon, Pfizer, Sepracor, and Wyeth, and received salary support through the NIMHresearch grant.