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

Chagas Disease Clinical Trial

— BIOMARCHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755377
• Other study ID #: BIOMARCHA
• Status: Completed
• Phase: N/A
• First received: December 19, 2012
• Last updated: August 19, 2016
• Start date: December 2012
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Barcelona Centre for International Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chagas Disease

Intervention

Drug:
• Benznidazole

Locations

Country	Name	City	State
Spain	International Health Department, Hospital Clinic, Barcelona	Barcelona	Cataluña

Sponsors (1)

Lead Sponsor	Collaborator
Barcelona Centre for International Health Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers for prognosis, early diagnosis and effectiveness of treatment.	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	2 years	No
Secondary	Cardiac function after antiparasitic treatment	- Correlation between biomarkers and alterations of the left ventricle diastolic function and segmentary contractility after antiparasitic treatment	2 years	No