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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01755377

Acronym

BIOMARCHA

Enrollment

Registered

2012-12-24

Start date

2012-12-31

Completion date

2016-06-30

Last updated

2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chagas Disease

Brief 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.

Interventions

DRUGBenznidazole

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Biomarkers for prognosis, early diagnosis and effectiveness of treatment.	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

Measure	Time frame	Description
Cardiac function after antiparasitic treatment	2 years	\- Correlation between biomarkers and alterations of the left ventricle diastolic function and segmentary contractility after antiparasitic treatment

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026