Selenium Treatment and Chagasic Cardiopathy (STCC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Oswaldo Cruz Foundation
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ministry of Health, Brazil
Information provided by (Responsible Party):
Tania Araujo-Jorge, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00875173
First received: October 20, 2008
Last updated: January 8, 2015
Last verified: January 2015
  Purpose

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. low Se levels is related to the severity of the myocardiopathy in chagasic patients
  2. adequate Se diet is essential for mice survival at the acute phase of the experimental T. cruzi infection
  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.

Methods:

The Selenium treatment and Chagasic Cardiopathy (STCC) trial is double-blind, placebo controlled, randomized in 130 chagasic patients at the chronic phase following the inclusion criteria of (a) altered ECHO (LVEF between 0,35 % and 45 %), (b) age between 20 and 65 years, (c) randomly divided in two groups: Placebo (n=65) and Se (n=65). Patients of Se group will intake diary 100 µg Se as sodium selenite for 12 months. The primary endpoint is the reduction of 50 % in the progression rate of heart dysfunction, and the secondary endpoint is a partial or total reversion in electrocardiography alterations.

Conclusion:

This trial was recently approved by Brazilian Research Ethics Committee and will be conducted in accordance with the principles for human experimentation. If the investigators confirmed the benefit of Se treatment, a strategy of utilization a micronutrient in an adequate concentration as a treatment in diary diet can revolutionize the therapeutic for chagasic myocardiopathy.


Condition Intervention Phase
Chagas Disease
Drug: Selenium
Drug: Placebo (for Selenium)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Selenium Treatment and Chagasic Cardiopathy (STCC): A Prospective Randomized Trial in Patients With Chagas Disease

Resource links provided by NLM:


Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • Ejection fraction by echocardiography [ Time Frame: Twice a year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Electrocardiography [ Time Frame: twice a year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: October 2008
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Selenium
Sodium selenite 100 micrograms in capsugel by mouth diary for 365 consecutive days
Drug: Selenium
selenium as a drug according to Brazilian regulation laws
Other Name: Antioxidant therapy
Active Comparator: Placebo
Capsugel for placebo (selenium 100 micrograms capsugel) by mouth diary for 365 consecutive days
Drug: Placebo (for Selenium)
Other Name: control

Detailed Description:

Several induced cardiomyopathy , Mycoplasma pneumonia-induced myocarditis, heart damage investigations have shown positive effects of Se on experimental models: cardiotoxicity induced by chemotherapics, ischemic cardiopathy, CVB3 and LP-BM5 (murine AIDS, retrovirus)-in reperfused heart, and in chagasic cardiopathy. In addition, beneficial effects of Se supplementation were reported in patients with myocardial infarct, Keshan disease, and cardiac dysfunction during HPN.

Our group has investigated the role and Se effect on infection by T. cruzi. By evaluating plasma Se levels in 170 chagasic patients, we discovered that the frequency of subjects with Se levels lower than normal was significantly higher in those with severe cardiopathy. Moreover, in this pioneering research, we found a positive correlation between Se levels and the LVEF, indicating that normal Se levels pave the way for efficient cardiac function. Later, we investigated if nutritional deficiency of this trace element interfered with the development of cardiopathy and the susceptibility to experimental T. cruzi infection. In that study, we found 100 % of mortality in Se deficient mice, while in the selenium adequate groups only 20% of the male and no female died even at 40 dpi. In addition, parasitemia levels of infected mice were not altered by Se deficiency, suggesting that the high susceptibility at the acute phase was not due to the parasite load. We later investigated if Se treatment could minimize the course of T. cruzi infection or the myocarditis in mice. We verified that the concentration of 4 ppm Se did not alter the resistance to infection but was able in preventing the increase of CK-MB levels in infected mice, indicating that Se helps to protect the heart from inflammatory damage driven by T. cruzi infection.

Currently, experimental and clinical trials concerning Se supplementation have been performed; however, to date, there is no trial regarding the use of this micronutrient as a treatment to protect cardiac function in chagasic patients with cardiopathy. The present clinical trial aims to study the effect of Se intervention on the progression rate of the cardiopathy in patients with mild or moderate HD (LVEF between 35 % and 45 %) in order to validate this new strategy of treatment. The HD will be expressed by the progression rate and by the comparison of means of the LVEF. In this context we will test the hypothesis that Se treatment is able to interfere with the progression of cardiac dysfunction in chronic chagasic patients. We expect the impediment of the progression of ventricular dysfunction in patients with mild HD, and the improvement of cardiac function in patients with moderate HD in the group of patients receiving Se therapy. This is the first clinical trial concerning this specific group of cardiac chagasic patients with mild or moderate HD.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875173

Contacts
Contact: Alejandro MH Moreno, MD 55 21 3865 9579 alejandro.hasslocher@ipec.fiocruz.br

Locations
Brazil
Instituto Nacional de Infectologia/Instituto de Pesquisa Clínica Evandro Chagas Recruiting
Rio de Janeiro, RJ, Brazil, 21040-360
Contact: Pedro EA Brasil, MD, PhD    213865-9648    pedro.brasil@ini.fiocruz.br   
Contact: TANIA CA JORGE, MD, PhD    212562-1295    taniaaj@ioc.fiocruz.br   
Sponsors and Collaborators
Oswaldo Cruz Foundation
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ministry of Health, Brazil
Investigators
Principal Investigator: Tania C Araujo-Jorge, MD/PhD Instituto Oswaldo Cruz
  More Information

Additional Information:
No publications provided by Oswaldo Cruz Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tania Araujo-Jorge, Full Professor,MD, PhD, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT00875173     History of Changes
Other Study ID Numbers: Oswaldo Cruz
Study First Received: October 20, 2008
Last Updated: January 8, 2015
Health Authority: Brazil: Ethics Committee

Keywords provided by Oswaldo Cruz Foundation:
Selenium
Chagas disease
Chagasic cardiopathy

Additional relevant MeSH terms:
Chagas Disease
Heart Diseases
Cardiovascular Diseases
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Trypanosomiasis
Selenium
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Trace Elements

ClinicalTrials.gov processed this record on May 26, 2015