Longitudinal Study of Patients With Chronic Chagas Cardiomyopathy in Brazil (SaMi_Trop Project)

NCT02646943 | Completed DMC

• 2 other identifiers: 2111129P50AI098461-02
• Study Type: observational
• Target: 1,959
• Locations: 0 countries
• Sites: N/A

Brief Summary

BACKGROUND: Chagas Disease (ChD) remains as one of the most neglected diseases in the world, with 8-10 million infected people and only one marginally effective therapeutic. The lack of good biomarkers for active infection or clinical end-points poses a problem for assessing the performance of new drugs or therapeutic interventions. Among the biomarkers, several studies showed that Brain Natriuretic Peptide (NT-ProBNP) is accurate maker of left ventricular systolic and diastolic dysfunction. OBJECTIVE: Our long term goal is to establish The Sao Paulo-Minas Gerais Tropical Medicine Research Center (SaMi-Trop) as a Center of Excellence for Neglected Infectious Disease Research in Brazil. The Specific Aims are to begin that process by focusing on Trypanosoma cruzi infection with the goal of finding an array of biomarkers that correlate with parasite persistence and Chagas cardiac disease status that can be used to infer risk of disease progression and death as well used as markers of cure (parasite eradication) or clinical efficacy (stabilize or reverse cardiac damage) of novel drugs METHOD: The investigators established a prospective cohort of 1,959 patients with chronic Chagas cardiomyopathy (CCC). The study is being conducted in 21 cities of the northern part of Minas Gerais state in Brazil, and includes a follow up of at least two years (baseline and 24 months) . The evaluation included collection of socio-demographic information, social determinants of health, health-related behaviours, comorbidities, medicines in use, history of previous treatment for Chagas Disease (ChD), symptoms, functional class, quality of life, blood sample collection and ECG.

Conditions

Chagas Disease

Keywords

Cohort; Biomarkers; Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Death

  24 months

Secondary Outcomes (2)

• Changes in the ECG pattern

  baseline and 24 months

• Hospitalization due to cardiovascular

  baseline and 24 months

Study Arms (1)

Cohort of patients with chronic chagas cardiomyopathy

We have established a prospective cohort of 1,959 patients with chronic Chagas cardiomyopathy (CCC) to evaluate if a clinical prediction rule based on electrocardiogram (ECG), Brain Natriuretic Peptide (BNP) levels and other biomarkers can be useful in clinical practice. The study is being conducted in 21 cities of the northern part of Minas Gerais state in Brazil, and includes a follow up of at least two years. The baseline evaluation included collection of socio-demographic information, social determinants of health, health-related behaviours, comorbidities, medicines in use, history of previous treatment for Chagas Disease (ChD), symptoms, functional class, quality of life, blood sample collection and ECG.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected based on the ECG results performed in 2011-12 by the Telehealth Network. Since the TeleHealth System is currently acting in support of the Primary Care system, these patients are under the care of primary care physicians of the Health Family Strategy, a public primary care program that has a high coverage in the state of Minas Gerais.

Sponsors & Collaborators

• University of Sao Paulo: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Federal University of Minas Gerais: collaborator
• Federal University of São João del-Rei: collaborator

Related Publications (43)

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• Talvani A, Rocha MO, Barcelos LS, Gomes YM, Ribeiro AL, Teixeira MM. Elevated concentrations of CCL2 and tumor necrosis factor-alpha in chagasic cardiomyopathy. Clin Infect Dis. 2004 Apr 1;38(7):943-50. doi: 10.1086/381892. Epub 2004 Mar 10.

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• Lula JF, Rocha MO, Nunes Mdo C, Ribeiro AL, Teixeira MM, Bahia MT, Talvani A. Plasma concentrations of tumour necrosis factor-alpha, tumour necrosis factor-related apoptosis-inducing ligand, and FasLigand/CD95L in patients with Chagas cardiomyopathy correlate with left ventricular dysfunction. Eur J Heart Fail. 2009 Sep;11(9):825-31. doi: 10.1093/eurjhf/hfp105. Epub 2009 Aug 4.

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• Ribeiro AL, dos Reis AM, Barros MV, de Sousa MR, Rocha AL, Perez AA, Pereira JB, Machado FS, Rocha MO. Brain natriuretic peptide and left ventricular dysfunction in Chagas' disease. Lancet. 2002 Aug 10;360(9331):461-2. doi: 10.1016/S0140-6736(02)09638-1.

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• Barbosa MM, Nunes Mdo C, Ribeiro AL, Barral MM, Rocha MO. N-terminal proBNP levels in patients with Chagas disease: a marker of systolic and diastolic dysfunction of the left ventricle. Eur J Echocardiogr. 2007 Jun;8(3):204-12. doi: 10.1016/j.euje.2006.03.011. Epub 2006 May 2.

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• Ribeiro AL, Reis AM, Teixeira MM, Rocha MO. Brain natriuretic peptide in Chagas' disease: further insights. Lancet. 2003 Jul 26;362(9380):333. doi: 10.1016/S0140-6736(03)13990-6. No abstract available.

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• Ribeiro AL, Teixeira MM, Reis AM, Talvani A, Perez AA, Barros MV, Rocha MO. Brain natriuretic peptide based strategy to detect left ventricular dysfunction in Chagas disease: a comparison with the conventional approach. Int J Cardiol. 2006 Apr 28;109(1):34-40. doi: 10.1016/j.ijcard.2005.05.048. Epub 2005 Jul 14.

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• Talvani A, Rocha MO, Cogan J, Maewal P, de Lemos J, Ribeiro AL, Teixeira MM. Brain natriuretic peptide and left ventricular dysfunction in chagasic cardiomyopathy. Mem Inst Oswaldo Cruz. 2004 Oct;99(6):645-9. doi: 10.1590/s0074-02762004000600020. Epub 2004 Nov 18.

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• Talvani A, Rocha MO, Cogan J, Maewal P, de Lemos J, Ribeiro AL, Teixeira MM. Brain natriuretic peptide measurement in Chagas heart disease: marker of ventricular dysfunction and arrhythmia. Int J Cardiol. 2005 Apr 28;100(3):503-4. doi: 10.1016/j.ijcard.2004.06.007. No abstract available.

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• Oliveira BM, Botoni FA, Ribeiro AL, Pinto AS, Reis AM, Nunes Mdo C, Rocha MO. Correlation between BNP levels and Doppler echocardiographic parameters of left ventricle filling pressure in patients with Chagasic cardiomyopathy. Echocardiography. 2009 May;26(5):521-7. doi: 10.1111/j.1540-8175.2008.00842.x.

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• Lima-Costa MF, Cesar CC, Peixoto SV, Ribeiro AL. Plasma B-type natriuretic peptide as a predictor of mortality in community-dwelling older adults with Chagas disease: 10-year follow-up of the Bambui Cohort Study of Aging. Am J Epidemiol. 2010 Jul 15;172(2):190-6. doi: 10.1093/aje/kwq106. Epub 2010 Jun 25.

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• Lima-Costa MF, Matos DL, Ribeiro AL. Chagas disease predicts 10-year stroke mortality in community-dwelling elderly: the Bambui cohort study of aging. Stroke. 2010 Nov;41(11):2477-82. doi: 10.1161/STROKEAHA.110.588061. Epub 2010 Sep 23.

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• Nunes Mdo C, Rocha MO, Ribeiro AL, Colosimo EA, Rezende RA, Carmo GA, Barbosa MM. Right ventricular dysfunction is an independent predictor of survival in patients with dilated chronic Chagas' cardiomyopathy. Int J Cardiol. 2008 Jul 21;127(3):372-9. doi: 10.1016/j.ijcard.2007.06.012. Epub 2007 Aug 8.

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• Nunes MC, Barbosa MM, Ribeiro AL, Colosimo EA, Rocha MO. Left atrial volume provides independent prognostic value in patients with Chagas cardiomyopathy. J Am Soc Echocardiogr. 2009 Jan;22(1):82-8. doi: 10.1016/j.echo.2008.11.015.

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• Ferreira AM, Santos LI, Sabino EC, Ribeiro ALP, Oliveira-da Silva LC, Damasceno RF, D'Angelo MFSV, Nunes MDCP, Haikal DSA. Two-year death prediction models among patients with Chagas Disease using machine learning-based methods. PLoS Negl Trop Dis. 2022 Apr 14;16(4):e0010356. doi: 10.1371/journal.pntd.0010356. eCollection 2022 Apr.

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• Quintino ND, Sabino EC, da Silva JLP, Ribeiro ALP, Ferreira AM, Davi GL, Oliveira CDL, Cardoso CS. Factors associated with quality of life in patients with Chagas disease: SaMi-Trop project. PLoS Negl Trop Dis. 2020 May 27;14(5):e0008144. doi: 10.1371/journal.pntd.0008144. eCollection 2020 May.

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• Cardoso CS, Ribeiro ALP, Oliveira CDL, Oliveira LC, Ferreira AM, Bierrenbach AL, Silva JLP, Colosimo EA, Ferreira JE, Lee TH, Busch MP, Reingold AL, Sabino EC. Beneficial effects of benznidazole in Chagas disease: NIH SaMi-Trop cohort study. PLoS Negl Trop Dis. 2018 Nov 1;12(11):e0006814. doi: 10.1371/journal.pntd.0006814. eCollection 2018 Nov.

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• Cardoso CS, Sabino EC, Oliveira CD, de Oliveira LC, Ferreira AM, Cunha-Neto E, Bierrenbach AL, Ferreira JE, Haikal DS, Reingold AL, Ribeiro AL. Longitudinal study of patients with chronic Chagas cardiomyopathy in Brazil (SaMi-Trop project): a cohort profile. BMJ Open. 2016 May 4;6(5):e011181. doi: 10.1136/bmjopen-2016-011181.

  PMID: 27147390 DERIVED

MeSH Terms

Conditions

Chagas Disease; Cardiomyopathies

Condition Hierarchy (Ancestors)

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

Study Officials

• Ester C Sabino, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 27, 2015
• First Posted: January 6, 2016
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 6, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share