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Safety and Efficacy of Sertraline for Depression in Patients With Heart Failure
Open accessAbstract
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, 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 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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Metadata
- 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
- 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)
- 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
- 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 (medical) › 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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