Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00875173
Other study ID # Oswaldo Cruz
Secondary ID
Status Recruiting
Phase Phase 3
First received October 20, 2008
Last updated November 9, 2015
Start date October 2008
Est. completion date December 2020

Study information

Verified date November 2015
Source Oswaldo Cruz Foundation
Contact Alejandro MH Moreno, MD
Phone 55 21 3865 9579
Email alejandro.hasslocher@ipec.fiocruz.br
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date December 2020
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Selenium
selenium as a drug according to Brazilian regulation laws
Placebo (for Selenium)
Placebo with similar flavor, smell and colour.

Locations

Country Name City State
Brazil Instituto Nacional de Infectologia/Instituto de Pesquisa Clínica Evandro Chagas Rio de Janeiro RJ

Sponsors (3)

Lead Sponsor Collaborator
Oswaldo Cruz Foundation Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ejection fraction by echocardiography Twice a year Yes
Secondary Electrocardiography twice a year Yes
See also
  Status Clinical Trial Phase
Completed NCT01162967 - Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole Phase 2
Completed NCT00023556 - Genetic Architecture of Heart Disease in Rural Brazil N/A
Active, not recruiting NCT04024163 - Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease Phase 3
Recruiting NCT05868005 - Delivering a Multi-disease Screening Tool to Migrant Populations N/A
Completed NCT03892213 - Pharmacokinetic Drug-Drug Interaction Study Phase 1
Recruiting NCT03704181 - Colchicine for Patients With Chagas´ Disease( B1 Stage) Phase 2
Active, not recruiting NCT03378661 - BENDITA BEnznidazole New Doses Improved Treatment and Associations Phase 2
Completed NCT01927224 - Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients Phase 1
Completed NCT01006486 - Outcomes of an Anticoagulation Clinic in an University Hospital Phase 4
Completed NCT00123916 - BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease Phase 3
Completed NCT02516293 - Cardiac Rehabilitation in Chagas Heart Failure Phase 2/Phase 3
Completed NCT02517632 - Physical Exercise Program in Chronic Chagas Heart Disease Phase 3
Recruiting NCT02099903 - Renal Denervation in Patients With Heart Failure Secondary to Chagas Disease N/A
Completed NCT01874795 - Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure N/A
Completed NCT01006473 - Exercise Training in Chagas Cardiomyopathy Phase 4
Completed NCT02386358 - Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial Phase 3
Not yet recruiting NCT05477953 - An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health
Completed NCT02346123 - Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy N/A
Recruiting NCT02295215 - Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction N/A
Completed NCT03350295 - Study Will Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mg Phase 1

External Links