Safety and Efficacy of Sertraline for Depression in Patients With Heart Failure

O'Connor, Christopher M.; Jiang, Wei; Kuchibhatla, Maragatha; Silva, Susan G.; Cuffe, Michael S.; Callwood, Dwayne D.; Zakhary, Bosh; Stough, Wendy Gattis; Arias, Rebekka M.; Rivelli, Sarah K.; Krishnan, Ranga

doi:10.1016/j.jacc.2010.03.068

Cited by 535Cardiac Health and Mental HealthTreatment of Major DepressionHeart Failure Treatment and Management

Safety and Efficacy of Sertraline for Depression in Patients With Heart Failure

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O'Connor, Christopher M., Jiang, Wei, Kuchibhatla, Maragatha, Silva, Susan G., Cuffe, Michael S., Callwood, Dwayne D., Zakhary, Bosh, Stough, Wendy Gattis +3 more·2010·Journal of the American College of Cardiology

DOI 10.1016/j.jacc.2010.03.068PMC PMC3663330

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Abstract

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 < or =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).

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Treating low mood can be done safely with pharmacological treatments such as selective serotonin reuptake inhibitors, whereas tricyclic antidepressants and monoamine oxidase inhibitors should be avoided because of the increased risk of arrhythmias or hypotension.
“Treating low mood can be done safely with pharmacological treatments such as selective serotonin reuptake inhibitors, 105 whereas tricyclic antidepressants and monoamine oxidase inhibitors should be avoided because of the increased risk of arrhythmias or hypotension. 106”
From Prioritizing symptom management in the treatment of chronic heart failure (2020) · cites this paper as [105]
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Other controlled trials have demonstrated modest improvements associated with SSRIs in patients with heart disease on surrogate markers, including heart rate variability and mental stress-induced myocardial ischemia, although other studies have found no such effect on clinical events or other markers.
“Other controlled trials have demonstrated modest improvements associated with SSRIs in patients with heart disease on surrogate markers, including heart rate variability 179 and mental stress-induced myocardial ischemia, 180 although other studies have found no such effect on clinical events or other markers. 179,181”
From Psychological Health, Well-Being, and the Mind-Heart-Body Connection: A Scientific Statement From the American Heart Association (2021) · cites this paper as [181]

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[20]Nair GV Gurbel PA O'Connor CM Gattis WA Murugesan SR Serebruany VL Depression, coronary events, platelet inhibition, and serotonin reuptake inhibitors Am J Cardiol 1999 84 321 3 A8 10496443

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Wang, Q., Dong, L., Jian, Z., & Tang, X. (2017) · BMC Cardiovascular Disorders · doi:10.1186/s12872-017-0698-8 · Cited by 63 · see citing works

Safety and Efficacy of Sertraline for Depression in Patients With Heart Failure: Results of the SADHART-CHF Trial
Krishnan, R. R., Jiang, W., Cuffe, M. S., Stough, W. G., Kuchibhatla, M. N., Arias, R. M., Zakhary, B., Silva, S. G., Callwood, D. D., O’Connor, C. M., et al. (2020) · Carolina Digital Repository (University of North Carolina at Chapel Hill) · doi:10.17615/k7ty-tx61 · Cited by 1 · see citing works
Self-citation
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
Jiang, W., O’Connor, C. M., Silva, S. G., Kuchibhatla, M. N., Cuffe, M. S., Callwood, D. D., Zakhary, B., Henke, E., Arias, R. M., & Krishnan, R. R. (2008) · American Heart Journal · doi:10.1016/j.ahj.2008.05.003 · Cited by 101 · see citing works
Self-citation
Safety and Efficacy of Sertraline plus Nurse Facilitated Supportive Intervention (NFSI) versus Placebo plus Nurse Facilitated Supportive Intervention for Depression in Patients with CHF (SADHART-CHF) (10/6/08)
O’Connor, C. M., Jiang, W., Silva, S. G., Kuchibhatla, M. N., Cuffe, M. S., Callwood, D. D., Zakhary, B., Henke, E., Arias, R. M., & Krishnan, R. R. (2008) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2008.10.011 · Cited by 5 · see citing works
Self-citation
Effects of Successful Depression Intervention on Health Status in Patients with Chronic Heart Failure and Major Depressive Disorder: Findings from the SADHART-CHF Randomized Controlled Trial
Fiuzat, M., Jiang, W., Spertus, J. A., Kuchibhatla, M. N., Cuffe, M. S., Krishnan, R. R., & O’Connor, C. M. (2009) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2009.06.069 · Cited by 1 · see citing works
Self-citation
Correspondence to
Trial, O. S.-C., Xiong, G. L., Fiuzat, M. M., Kuchibhatla, M. N., Krishnan, R., Christopher, M., Jiang, W., & Xiong, G. L. (2016)
Self-citation

Authors: O'Connor, C. M., Jiang, W., Kuchibhatla, M., Silva, S. G., Cuffe, M. S., Callwood, D. D., Zakhary, B., Stough, W. G., Arias, R. M., Rivelli, S. K., & Krishnan, R.
Affiliations: Duke Medical Center (US)
Duke University (US)
University of North Carolina at Chapel Hill (US)
Virginia Research Institute (US)
Campbell University (US)
ORCID: Jiang, Wei
Kuchibhatla, Maragatha
Silva, Susan G.
Stough, Wendy Gattis
Arias, Rebekka M.
Krishnan, Ranga
Venue: Journal of the American College of Cardiology
Publisher: Elsevier BV
Published: 2010-08
Volume: 56
Issue: 9
Pages: 692-699
ISSN: 0735-1097 (ISSN-L)
DOI: 10.1016/j.jacc.2010.03.068
PMC: PMC3663330
OpenAlex: W1608367062
Cited by: 535
References: 36
Citations by year: 2026: 29 · 2025: 23 · 2024: 21 · 2023: 28 · 2022: 35 · 2021: 27 · 2020: 40 · 2019: 49 · 2018: 35 · 2017: 39 · 2016: 42 · 2015: 36 · 2014: 23 · 2013: 38 · 2012: 37
FWCI: 23.49
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 1080 d)
Locations: Journal of the American College of Cardiology (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Institute of Mental Health
Pfizer, Inc.
NIMH
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
Keywords: sertraline, heart failure, depression, major depressive disorder, antidepressants, cardiovascular events, drug safety, depression severity
MeSH terms: Aged, Antidepressive Agents, Chronic Disease, Depression, Female, Heart Failure, Humans, Male, Middle Aged, Sertraline

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Safety and Efficacy of Sertraline for Depression in Patients With Heart Failure

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