Rationale and design of a randomised, controlled, multicenter trial investigating the effects of selective serotonin re-uptake inhibition on morbidity, mortality and mood in depressed heart failure patients (MOOD-HF)
Rationale and design of a randomised, controlled, multicenter trial investigating the effects of selective serotonin re-uptake inhibition on morbidity, mortality and mood in depressed heart failure patients (MOOD-HF)
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DOI：
10.1016/j.ejheart.2007.10.005
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发表时间：
2007-12-01
影响因子：
18.2
通讯作者：
Ertl, Georg
中科院分区：
文献类型：
--
作者：
Angermann, Christiane E.;Gelbrich, Goetz;Ertl, Georg
背景：抑郁症和慢性心力衰竭（CHF）是常见的疾病，两者在临床和经济上高度相关。重度抑郁症影响20-40%的CHF患者，并预测生活质量、发病率和死亡率以及医疗保健支出方面的不良结局，与其他预后相关因素无关。目的：MOOD-HF试验的目的是阐明抗抑郁药物治疗是否改善CHIF患者的结局，如果是，通过何种机制改善。方法：MOOD-HF是一项前瞻性、随机、双盲、安慰剂对照、双臂、平行组、多中心试验，旨在研究scrotonin再摄取抑制剂（SSRI）艾司西酞普兰对发病率和死亡率的影响（主要终点），抑郁、焦虑、认知功能的严重程度，通过结构化临床访谈诊断的700例症状性收缩期CHF和抑郁症患者的生活质量和医疗费用。所有患者将接受优化的CHF药物治疗。随访的持续时间，包括密切的安全性监测，是12-24个月从randomisation.Perspective：MOOD-HF是第一个前瞻性随机对照试验，以评估抗抑郁药物治疗对硬躯体终点的影响，SSRI治疗的作用机制，以及纽约心脏协会功能分级II-IV CHIF患者的安全性。这些结果有望促进CHF背景下管理抑郁症的循证建议的发展。试验注册：ISRCTN. org。标识符：ISRCTN 33128015（c）2007欧洲心脏病学会。出版社：Elsevier B.V版权所有。
Background: Depression and chronic heart failure (CHF) are common conditions, both of which are clinically and economically highly relevant. Major depression affects 20-40% of CHF patients and predicts adverse outcomes in terms of quality of life, morbidity and mortality as well as health care expenditure, independent of other factors of prognostic relevance.Aims: The purpose of the MOOD-HF trial is to clarify whether antidepressant pharmacotherapy improves outcome in CHIF patients, and if so by which mechanism(s).Methods: MOOD-HF is a prospective, randomised, double-blind, placebo-controlled, 2-armed, parallel-group multicenter trial investigating the effects of the scrotonin re-uptake inhibitor (SSRI) escitalopram on morbidity and mortality (primary endpoint), severity of depression, anxiety, cognitive function, quality of life and health care expenditure in 700 patients with symptomatic systolic CHF and major depression diagnosed by structured clinical interview. All patients will receive optimised phannacotherapy for CHF. Duration of follow-up, including close safety monitoring, is 12-24 months from randomisation.Perspective: MOOD-HF is the first prospective randomised controlled trial to assess the effects of antidepressant pharmacotherapy on hard somatic endpoints, the mechanism(s) of action of SSRI treatment, as well as safety in New York Heart Association functional class II-IV CHIF patients. The results are expected to promote the development of evidence-based recommendations for managing depression in the context of CHF. Trial registration: ISRCTN.org. Identifier: ISRCTN33128015 (c) 2007 European Society of Cardiology. Published by Elsevier B.V All rights reserved.