Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial

Abstract

BackgroundHeart 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.MethodsThe 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.DiscussionIf 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.Trial registrationClinical Trials.gov ID: NCT00875173 (registered 20 October 20 2008).

Selenium in Cardiac Surgery

“…In clinical trials, the most commonly used selenocompound is sodium selenite, which is administered either intravenously or orally. The concentrations of oral administration differ from 100 up to 4000, or 1000 μg/d intravenously . Since the administration form and concentration vary considerably, the time points of administration are also ill defined, and different regimens have been tested.…”

Selenium and Its Supplementation in Cardiovascular Disease—What do We Know?

“…Previous studies demonstrated poor outcome in Chagasic cardiomyopathy, which was associated with low selenium levels in an animal model. Currently, the Selenium Treatment and Chagasic Cardiopathy (STCC) study [ 107 ], is evaluating in adult patients with mild or moderate global left ventricular systolic dysfunction, the efficacy of selenium supplementation given as a daily dose of 100 μg sodium selenite during 12 consecutive months compared to placebo.…”

Developments in the management of Chagas cardiomyopathy

“…These drug strategies are based on the reported efficacy of nitric oxide (NO) and its related bioactive forms,[174–176] curcumin [177] and selenium. [178,179] Two of these (NO and curcumin) also hold promise with respect to limiting infectivity. A major limitation in translating the promising preclinical studies into actual therapies that can be deployed and administered in a cost- and time-effective manner is the issue of drug delivery with respect to enhancing bioavailability, rate and duration of delivery, mode of delivery and site-specific targeting to tissues.…”