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.

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.
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DOI:
10.1016/j.ahj.2008.05.003
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发表时间:
2008-09
影响因子:
4.8
通讯作者:
Krishnan, Ranga
Krishnan, Ranga
中科院分区:
医学2区
文献类型:
--
作者:
Jiang, Wei;O'Connor, Christopher;Silva, Susan G.;Kuchibhatla, Maragatha;Cuffe, Michael S.;Callwood, Dwayne D.;Zakhary, Bosh;Henke, Elizabeth;Arias, Rebekka M.;Krishnan, Ranga

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舍曲林是一种选择性5 - 羟色胺再摄取抑制剂(SSRI),已证实在心肌梗死后或不稳定型心绞痛患者中能显著改善情绪。舍曲林对慢性心力衰竭(HF)合并重度抑郁症(MDD)患者的预后和抑郁的影响尚不明确。 这是一项前瞻性、随机、双盲、安慰剂对照研究,旨在评估舍曲林治疗心力衰竭患者重度抑郁症的安全性和有效性。该研究还旨在检验治疗抑郁症对心力衰竭患者心脏事件以及发病率/死亡率的影响。研究人群包括约500名年龄≥45岁、患有当前重度抑郁症和慢性收缩性心力衰竭的男性和女性,其特征为左心室射血分数(LVEF)≤45%且纽约心脏协会(NYHA)心功能分级≥II级。符合条件的参与者被随机分配接受舍曲林或安慰剂治疗,为期12周的急性治疗阶段。所有患者,无论是否完成急性治疗阶段,都要常规随访,直至最后一名受试者完成6个月的随访。在基线和急性治疗阶段结束时测量生活质量和某些生理参数,以及可能反映舍曲林在这一特定人群中影响的促炎和心力衰竭生物标志物。 由于抑郁症的高患病率及其对缺血性心脏病和心力衰竭患者预后的重大不利影响,SADHART - HF试验旨在评估舍曲林对抑郁症的疗效以及对心力衰竭患者心脏预后的影响。
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. 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. 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.
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