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

Chagas Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524768
• Other study ID #: CHAGASKASALTIBIRIÇÁ
• Status: Completed
• Start date: August 20, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: National Institute of Cardiology, Laranjeiras, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients presenting with Chagas cardiomyopathy

Exclusion Criteria:

• diabetes

Related Conditions & MeSH terms

• Cardiomyopathies
• Chagas Cardiomyopathy
• Chagas Disease

Intervention

Diagnostic Test:
• skin laser speckle contrast imaging and video-capillaroscopy
Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment

Locations

Country	Name	City	State
Brazil	National Institute of Cardiology, Ministry of Health, Brazil	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelium-dependent skin microvascular function	systemic microvascular vasodilation induced by endothelium-dependent agents	2 hours
Secondary	Endothelium-dependent skin capillary density	capillary opening induced by post-occlusive reactive hyperemia	1 hour