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OpenTrials
Completed

NCT Number: NCT01755377

New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease

Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.

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Key information

Conditions

Chagas Disease Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

International Health Department, Hospital Clinic, Barcelona

Barcelona, Catalonia, 08036, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients from endemic areas (Latin America)
  • Older than 18 years old and younger than 50
  • With serological confirmation of Chagas Disease infection with two different techniques
  • Indeterminate or initial cardiac form
  • No previously treated for Chagas Disease

Exclusion criteria

  • Co-morbidity: previous cardiac disease from other aetiology (ischemic, alcoholic or hypertensive), active inflammatory or immunology diseases for another agent. Hepatic disfunction
  • Pregnancy or lactation

Treatment and study plan

Benznidazole

Drug

Primary outcomes

  1. Biomarkers for prognosis, early diagnosis and effectiveness of treatment.

    Time frame: 2 years

    • Conventional polymerase chain reaction of T. cruzi in blood
    • Measurement of Brain natriuretic factor
    • Measurement of Prothrombotic factors
    • Measurement of antibodies against specific proteins of the trypomastigote of T. cruzi
    • Investigation of the phylogenetics of the parasite and the role of the lineages of T.cruzi in the clinical presentation and disease's progression

Secondary outcomes

  1. Cardiac function after antiparasitic treatment

    Time frame: 2 years

    • Correlation between biomarkers and alterations of the left ventricle diastolic function and segmentary contractility after antiparasitic treatment

Sponsors and collaborators

Lead sponsor

Barcelona Centre for International Health Research

Other

Registry information

Official study title

Evolution of Serologic Biomarkers and Diastolic Function and Segmentary Contractility Determined by Echocardiography After Treatment in Chagas Diseases

Acronym: BIOMARCHA

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2012
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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