Selenium Treatment and Chagasic Cardiopathy (STCC)

NCT00875173 | Unknown Phase 3 DMC

• 1 other identifier: Oswaldo Cruz
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Chagasic myocardiopathy caused by the protozoa Trypanosoma cruzi has been the principal cause of cardiac death in Latin America. Without any trypanocidal therapeutic intervention, infected subjects can pass from the indeterminate to the cardiac form with heart dysfunction. Our group has studied the role and the effect of the supplementation with the essential micronutrient selenium (Se) on T. cruzi infection, and the investigators have verified that:

1. 1.low Se levels is related to the severity of the myocardiopathy in chagasic patients
2. 2.adequate Se diet is essential for mice survival at the acute phase of the experimental T. cruzi infection
3. 3.Se supplementation prevented the myocardial lesions at the acute phase in mice. From these findings and considering that Se supplementation was able to prevent Keshan cardiopathy, to revert electrocardiographic and echocardiographic alterations in patients nourished by parenteral route, and reduced re-infarction and cardiac deaths from acute myocardial infarction; the investigators purpose to investigate if Se treatment via oral route, is able to impair the progress of heart dysfunction in chagasic patients expressed by the study of progression rate and by the comparison of the means of ventricular ejection fraction.

Conditions

Chagas Disease

Keywords

Selenium; Chagas disease; Chagasic cardiopathy

Outcome Measures

Primary Outcomes (1)

• Ejection fraction by echocardiography

  Twice a year

Secondary Outcomes (1)

• Electrocardiography

  twice a year

Study Arms (2)

Selenium

EXPERIMENTAL

Sodium selenite 100 micrograms in capsugel by mouth diary for 365 consecutive days

Drug: Selenium

Placebo

ACTIVE COMPARATOR

Capsugel for placebo (selenium 100 micrograms capsugel) by mouth diary for 365 consecutive days

Drug: Placebo (for Selenium)

Interventions

Selenium DRUG

selenium as a drug according to Brazilian regulation laws

Also known as: Antioxidant therapy

Selenium

Placebo (for Selenium) DRUG

Placebo with similar flavor, smell and colour.

Also known as: control

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• altered ECHO (LVEF between 0,35 % and 45 %)
• age between 20 and 65 years

You may not qualify if:

• patients \> 65 years of age
• smoke habit, patients with non-chagasic cardiopathy, live close to mineral deposit, metals industries and place with radioactive exposition, vegetarian
• depressive psychological profile
• pregnant or in lactating period
• present or presented cancer or diabetes.
• patients will be excluded if they take anti-convulsive medicines (Clozapine, Valproic Acid)

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Instituto Nacional de Infectologia/Instituto de Pesquisa Clínica Evandro Chagas

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

RECRUITING

Related Publications (3)

• Holanda MT, Mediano MFF, Hasslocher-Moreno AM, Gonzaga BMS, Carvalho ACC, Ferreira RR, Garzoni LR, Pereira-Silva FS, Pimentel LO, Mendes MO, Azevedo MJ, Britto C, Moreira OC, Fernandes AG, Santos CM, Constermani J, Paravidino VB, Maciel ER, Carneiro FM, Xavier SS, Sperandio da Silva GM, Santos PF, Veloso HH, Brasil PEAA, de Sousa AS, Bonecini-de-Almeida MG, da Silva PS, Sangenis LHC, Saraiva RM, Araujo-Jorge TC. Effects of Selenium treatment on cardiac function in Chagas heart disease: Results from the STCC randomized Trial. EClinicalMedicine. 2021 Aug 28;40:101105. doi: 10.1016/j.eclinm.2021.101105. eCollection 2021 Oct.

  PMID: 34485877 DERIVED

• Holanda MT, Mediano MFF, Hasslocher-Moreno AM, Xavier SS, Saraiva RM, Sousa AS, Maciel ER, Carneiro FM, da Silva PS, Sangenis LHC, Veloso HH, Cardoso CSA, Bonecini-Almeida MDG, Souza AL, Roma EH, Azevedo MJ, Pereira-Silva FS, Pimentel LO, Mendes MO, Garzoni LR, Gonzaga BMS, Carvalho ACC, Brasil PEAA, Sperandio da Silva GM, Araujo-Jorge TC. A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial. Trials. 2018 Sep 19;19(1):507. doi: 10.1186/s13063-018-2889-8.

  PMID: 30231899 DERIVED

• Alvarenga Americano do Brasil PE, Pereira de Souza A, Hasslocher-Moreno AM, Xavier SS, Lambert Passos SR, de Fatima Ramos Moreira M, Santini de Oliveira M, Sperandio da Silva GM, Magalhaes Saraiva R, Santos de Aguiar Cardoso C, de Sousa AS, Mediano MF, Bonecini de Almeida Mda G, da Cruz Moreira O, Britto C, de Araujo-Jorge TC. Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial. Trials. 2014 Oct 6;15:388. doi: 10.1186/1745-6215-15-388.

  PMID: 25284194 DERIVED

Related Links

• Instituto Oswaldo Cruz

MeSH Terms

Conditions

Chagas Disease

Interventions

Selenium

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Tania C Araujo-Jorge, MD/PhD

  Instituto Oswaldo Cruz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro MH Moreno, MD

CONTACT

55 21 3865 9579; alejandro.hasslocher@ipec.fiocruz.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor,MD, PhD

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: April 3, 2009
• Study Start: October 1, 2008
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2020
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

BR (1)