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.

Abstract

Purpose: We have established a prospective cohort of 1959 patients with chronic Chagas cardiomyopathy to evaluate if a clinical prediction rule based on ECG, brain natriuretic peptide (BNP) levels, and other biomarkers can be useful in clinical practice. This paper outlines the study and baseline characteristics of the participants.

Participants: The study is being conducted in 21 municipalities of the northern part of Minas Gerais State in Brazil, and includes a follow-up of 2 years. The baseline evaluation included collection of sociodemographic information, social determinants of health, health-related behaviours, comorbidities, medicines in use, history of previous treatment for Chagas disease, functional class, quality of life, blood sample collection, and ECG. Patients were mostly female, aged 50-74 years, with low family income and educational level, with known Chagas disease for >10 years; 46% presented with functional class >II. Previous use of benznidazole was reported by 25.2% and permanent use of pacemaker by 6.2%. Almost half of the patients presented with high blood cholesterol and hypertension, and one-third of them had diabetes mellitus. N-terminal of the prohormone BNP (NT-ProBNP) level was >300 pg/mL in 30% of the sample.

Findings to date: Clinical and laboratory markers predictive of severe and progressive Chagas disease were identified as high NT-ProBNP levels, as well as symptoms of advanced heart failure. These results confirm the important residual morbidity of Chagas disease in the remote areas, thus supporting political decisions that should prioritise in addition to epidemiological surveillance the medical treatment of chronic Chagas cardiomyopathy in the coming years. The São Paulo-Minas Gerais Tropical Medicine Research Center (SaMi-Trop) represents a major challenge for focused research in neglected diseases, with knowledge that can be applied in primary healthcare.

Future plans: We will continue following this patients' cohort to provide relevant information about the development and progression of Chagas disease in remotes areas, with social and economic inequalities.

Trial registration number: NCT02646943; Pre-results.

Keywords: Biomarkers; CHEMICAL PATHOLOGY; Chagas disease; Cohort Studies.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Biomarkers / blood
  • Brazil / epidemiology
  • Chagas Cardiomyopathy / blood
  • Chagas Cardiomyopathy / drug therapy
  • Chagas Cardiomyopathy / epidemiology*
  • Chagas Cardiomyopathy / physiopathology
  • Chronic Disease / drug therapy
  • Chronic Disease / epidemiology*
  • Disease Progression
  • Female
  • Follow-Up Studies
  • Heart Failure / epidemiology*
  • Heart Failure / physiopathology
  • Heart Failure / prevention & control
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Natriuretic Peptide, Brain / blood*
  • Nitroimidazoles / therapeutic use*
  • Peptide Fragments / blood*
  • Population Surveillance
  • Predictive Value of Tests
  • Prognosis
  • Prospective Studies
  • Quality of Life
  • Socioeconomic Factors

Substances

  • Biomarkers
  • Immunosuppressive Agents
  • Nitroimidazoles
  • Peptide Fragments
  • pro-brain natriuretic peptide (1-76)
  • Natriuretic Peptide, Brain
  • benzonidazole

Associated data

  • ClinicalTrials.gov/NCT02646943