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

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ClinicalTrials.gov Identifier: NCT02646943
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : January 6, 2016
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Federal University of Minas Gerais
Federal University of São João del-Rei
Information provided by (Responsible Party):
Ester Cerdeira Sabino, University of Sao Paulo

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.


Condition or disease
Chagas Disease

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 1959 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study of Patients With Chronic Chagas Cardiomyopathy in Brazil (SaMi_Trop Project)
Study Start Date : July 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Group/Cohort
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.




Primary Outcome Measures :
  1. Death [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Changes in the ECG pattern [ Time Frame: baseline and 24 months ]
  2. Hospitalization due to cardiovascular [ Time Frame: baseline and 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Eligibility Criteria: to be a client of the TMS TeleHealth System, have a positive history for T cruzi infection or Chagas disease, have an abnormal ECG and to consent to participating in the research program.

Exclusion Criteria: The exclusion criteria include pregnancy or breast feeding, and any severe condition with ominous prognosis that indicates a life expectancy of less than two years.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646943


Sponsors and Collaborators
University of Sao Paulo
National Institute of Allergy and Infectious Diseases (NIAID)
Federal University of Minas Gerais
Federal University of São João del-Rei
Investigators
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Principal Investigator: Ester C Sabino, PhD University of São Paulo

Publications of Results:

Other Publications:
Harrell FE, Jr. Regression modeling strategies with applications to linear models, logistic regression, and survival analysis. New York: Springer, 2001.
Steyerberg EW. Clinical Prediction Models. A Practical Approach to Development,Validation, and Updating. New York: Springer, 2009.
Ribeiro AL, Lombardi F, Colosimo EA, Nunes MC, Rocha MO. Risk Stratification in Chagas Disease: Further Improvements are Needed. J Cardiovasc Electrophysiol 2008; 19(6):E41-E43.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ester Cerdeira Sabino, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02646943     History of Changes
Other Study ID Numbers: 2111129
P50AI098461-02 ( U.S. NIH Grant/Contract )
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dataset will be open access for two years at the end of the data collection process (August, 2018). In the meantime, applications to use the data should be made by contacting the researchers of the SaMi-Trop cohort and filling up the application form. The questionnaires and interviewer guides of the baseline will also be available in electronic formats at http://www.ufsj.edu.br/tecnologiasemsaude_pesquisa/projetos.php
Keywords provided by Ester Cerdeira Sabino, University of Sao Paulo:
Cohort
Biomarkers
Cardiomyopathy
Additional relevant MeSH terms:
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Chagas Disease
Chagas Cardiomyopathy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases