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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.


Detailed Summary:

RESEARCH STRATEGY

SIGNIFICANCE

The Sao Paulo-Minas Gerais Tropical Medicine Research Center (SaMi-Trop) consists of a network of collaborating scientists in the States of Minas Gerais and São Paulo which has been established for the purpose of developing and conducting research projects on neglected infectious diseases in Brazil, with an initial focus on Chagas Disease biomarker, discovery and validation. The SaMi-Trop represents a major challenge for focused research in neglected diseases, with knowledge that can be applied in primary health care.

Chronic Chagas Cardiomyopathy (CCC) is the most important clinical presentation of Chagas Disease (ChD), eventually affecting approximately 20% to 30% of those in the chronic phase of the disease. CCC comprises a wide range of manifestations, including heart failure, arrhythmias, heart-blocks, sudden death, thromboembolism and stroke [1]. Clinical presentation typically varies widely according to the degree of myocardial damage and most patients present a mild form of heart disease, frequently characterized only by the presence of asymptomatic abnormalities on the ECG or in other complimentary exams [2]. Nonetheless, when heart failure and/or severe arrhythmias manifest, the prognosis is ominous, with high and premature mortality rates, typically in adult male patients,1 but also in the elderly [3]. Indeed, when compared to patients with idiopathic cardiomyopathy, patients with CCC have poorer survival, irrespective of other clinical and echocardiographic parameters [4].

Thus, the clinical course of Chagas heart disease is variable and identifying patients who are at risk of progressive CCC and dying remains a challenge. Several longitudinal studies performed in patients in t
Sponsor: University of Sao Paulo

Current Primary Outcome: Death [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in the ECG pattern [ Time Frame: baseline and 24 months ]
  • Hospitalization due to cardiovascular [ Time Frame: baseline and 24 months ]


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: December 27, 2015
Date Started: July 2013
Date Completion:
Last Updated: January 5, 2016
Last Verified: January 2016