Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03524768
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

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.

Condition or disease Intervention/treatment
Chagas Cardiomyopathy Diagnostic Test: skin laser speckle contrast imaging and video-capillaroscopy

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients presenting with Chagas cardiomyopathy
Evaluation of systemic microvascular reactivity using laser speckle contrast imaging Evaluation of skin capillary density using video-capillaroscopy
Diagnostic Test: skin laser speckle contrast imaging and video-capillaroscopy
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
Diagnostic Test: skin laser speckle contrast imaging and video-capillaroscopy
Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment




Primary Outcome Measures :
  1. Endothelium-dependent skin microvascular function [ Time Frame: 2 hours ]
    systemic microvascular vasodilation induced by endothelium-dependent agents


Secondary Outcome Measures :
  1. Endothelium-dependent skin capillary density [ Time Frame: 1 hour ]
    capillary opening induced by post-occlusive reactive hyperemia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients presenting with the cardiac form of Chagas disease in the National Institute of Cardiology, Ministry of Health, Rio de Janeiro,, Brazil
Criteria

Inclusion Criteria:

  • patients presenting with Chagas cardiomyopathy

Exclusion Criteria:

  • diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524768


Locations
Layout table for location information
Brazil
National Institute of Cardiology, Ministry of Health, Brazil Recruiting
Rio de Janeiro, Brazil, 22240-006
Contact: Eduardo V Tibirica, MD, PhD    +55-21-999146075    etibi@uol.com.br   
Sponsors and Collaborators
National Institute of Cardiology, Laranjeiras, Brazil

Layout table for additonal information
Responsible Party: Eduardo Tibirica, MD, PhD, Senior Researcher, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier: NCT03524768     History of Changes
Other Study ID Numbers: CHAGASKASALTIBIRIÇÁ
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil:
endothelial function, microvascular
laser speckle contrast imaging
capillaroscopy, skin
Additional relevant MeSH terms:
Layout table for MeSH terms
Chagas Disease
Chagas Cardiomyopathy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases