Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.

NCT ID: NCT03524768

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2020-08-01

Brief Summary

The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients with the cardiac form of Chagas disease, and to search for associations with clinical and laboratory variables.

Detailed Description

Chagas disease is an endemic anthropozoonosis in South America, caused by the protozoaTrypamosoma cruzi. Between 15 and 17 million people are estimated to be infected by the parasite in South America. During the chronic phase, 30 to 40% of patients develop the cardiac or intestinal forms of the disease. The myocardial involvement is divided in two subtypes, according to the presence or absence of systolic ventricular dysfunction. The first type is characterized by heart failure symptoms. The second is acknowledged by the development of various degrees of atrioventricular blockade and by tachyarrhythmias.

Microcirculation function is recognized as a fundamental aspect in the pathophysiology of cardiovascular diseases. The identification of endothelial dysfunction by techniques that assess the microvasculature is considered as both a progression and prognostic marker in various conditions, including hypertension, coronary heart disease, and heart failure.

The effects of T. cruzi infection in vascular function were evaluated in previous studies, performed in animals with acute infection. Previous studies in humans observed medium size vessels (brachial artery), in small groups of patients, most without cardiac dysfunction. There are no studies evaluating the microcirculation of patients with the cardiac form of Chagas disease.

Conditions

Chagas Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients presenting with Chagas cardiomyopathy

Evaluation of systemic microvascular reactivity using laser speckle contrast imaging Evaluation of skin capillary density using video-capillaroscopy

skin laser speckle contrast imaging and video-capillaroscopy

Intervention Type: DIAGNOSTIC_TEST

Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment

control group

Evaluation of systemic microvascular reactivity using laser speckle contrast imaging Evaluation of skin capillary density using video-capillaroscopy

skin laser speckle contrast imaging and video-capillaroscopy

Intervention Type: DIAGNOSTIC_TEST

Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment

Interventions

skin laser speckle contrast imaging and video-capillaroscopy

Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• patients presenting with Chagas cardiomyopathy

Exclusion Criteria

• diabetes

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eduardo Tibirica, MD, PhD

Senior Researcher, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, , Brazil

Countries

Brazil

Other Identifiers

CHAGASKASALTIBIRIÇÁ

Identifier Type: -

Identifier Source: org_study_id