Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial.
Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial.
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DOI：
10.1186/1745-6215-15-388
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发表时间：
2014-10-06
期刊：
影响因子：
2.5
通讯作者：
de Araújo-Jorge TC
中科院分区：
文献类型：
--
作者：
Alvarenga Americano do Brasil PE;Pereira de Souza A;Hasslocher-Moreno AM;Xavier SS;Lambert Passos SR;de Fátima Ramos Moreira M;Santini de Oliveira M;Sperandio da Silva GM;Magalhães Saraiva R;Santos de Aguiar Cardoso C;de Sousa AS;Mediano MF;Bonecini de Almeida Mda G;da Cruz Moreira O;Britto C;de Araújo-Jorge TC
30%的慢性克氏锥虫感染患者发生心脏病进展。在T. cruzi感染产生了有希望的结果。有证据表明，恰加斯心脏病患者的硒水平低于健康个体和恰加斯心脏病患者。无心脏病的克氏感染。本研究的目的是评估硒治疗对预防冠心病患者心脏病进展的影响。硒治疗和心脏病试验是一项优效、双盲、安慰剂对照、随机临床试验。合格标准如下：（1）经血清学证实的恰加斯病诊断;（2）节段性、轻度或中度整体左心室收缩功能障碍;（3）年龄在18至65岁之间。排除标准如下：（1）妊娠，（2）糖尿病，（3）吸烟，（4）酗酒，（5）非胆固醇性心脏病证据，（6）抑郁症，（7）吞咽困难伴食管内食物残留证据，（8）吞咽困难，在过去四个月内体重减轻超过正常体重的15%，和/或（9）可能导致方案依从性低的情况。与安慰剂相比，干预措施为每天一次100 μg亚硒酸钠，连续365天。以下是要测量的主要结局：（1）随访期间左心室射血分数的轨迹;（2）心脏病进展率的降低，进展定义为左心室射血分数降低10%;（3）可归因于心律失常、心力衰竭或恰加斯病引起的卒中的住院率。130例患者将以1：1的比例随机分配至干预组或安慰剂组。计划采用编号盒策略进行序列分配隐藏和设盲。在5年随访期间，患者和医疗保健提供者将对干预组保持盲态。如果硒治疗可以减少恰加斯心脏病的进展，那么在日常饮食中加入这种微量营养素可以以低成本改善这种被忽视的热带疾病的治疗方案。临床Trials.gov ID：NCT 00875173（注册日期：2008年10月20日）。
Heart disease progression occurs in 30% of patients with chronic Trypanosoma cruzi infection. Supplementation with selenium (Se) in animal model of T. cruzi infection produced promising results. There is evidence that patients with Chagas heart disease have lower Se levels than healthy individuals and patients with T. cruzi infection without of cardiac disease. The aim of this investigation is to estimate the effect of Se treatment on prevention of heart disease progression in patients with chagasic cardiopathy. The Selenium Treatment and Chagasic Cardiopathy trial is a superiority, double-blind, placebo-controlled, randomized clinical trial. The eligibility criteria are as follows: (1) a Chagas disease diagnosis confirmed by serology; (2) segmental, mild or moderate global left ventricular systolic dysfunction; and (3) age between 18 and 65 years. The exclusion criteria are as follows: (1) pregnancy, (2) diabetes mellitus, (3) tobacco use, (4) alcohol abuse, (5) evidence of nonchagasic heart disease, (6) depression, (7) dysphagia with evidence of food residues in the esophagus, (8) dysphagia with weight loss higher than 15% of usual weight in the last four months and/or (9) conditions that may result in low protocol adherence. The intervention will be 100 μg of sodium selenite once daily for 365 consecutive days compared to placebo. The following are the primary outcomes to be measured: (1) the trajectories of the left ventricular ejection fraction in the follow-up period; (2) reduction of heart disease progression rates, with progression defined as a 10% decrease in left ventricular ejection fraction; and (3) rate of hospital admissions attributable to dysrhythmia, heart failure or stroke due to Chagas disease. One hundred thirty patients will be randomly allocated into either the intervention or placebo group at a ratio of 1:1. The sequence allocation concealment and blinding were planned to be conducted with the strategy of numbered boxes. Both patients and health-care providers will remain blinded to the intervention groups during the 5 years of follow-up. If Se treatment reduces the progression of Chagas cardiopathy, the inclusion of this micronutrient in the daily diet can improve the therapeutic regimen for this neglected tropical disease at low cost. Clinical Trials.gov ID: NCT00875173 (registered 20 October 20 2008).
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影响因子：
3.3
作者：
LI, G;WANG, F;LI, C
通讯作者：
LI, C
影响因子：
3.9
作者：
KOEHLER, H;PETERS, HJ;DUCK, HJ
通讯作者：
DUCK, HJ
影响因子：
3.4
作者：
KAVANAUGHMCHUGH, AL;RUFF, A;ROWE, S
通讯作者：
ROWE, S
DOI：
10.1111/j.1749-6632.1990.tb00146.x
发表时间：
1990-05-15
影响因子：
5.2
作者：
BOGDEN, JD;BAKER, H;LOURIA, D
通讯作者：
LOURIA, D
影响因子：
2.8
作者：
Fleck, MPA;Louzada, S;Pinzon, V
通讯作者：
Pinzon, V