Chagas CardiomyopathyNCT03524768
Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.
An observational study of Chagas Cardiomyopathy, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chagas Cardiomyopathy
- What is being tested?
- skin laser speckle contrast imaging and video-capillaroscopy
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2018to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- patients presenting with Chagas cardiomyopathy
Who cannot join
- diabetes
Trial locations and contacts
1 site in 1 country.
Brazil1 site
National Institute of Cardiology, Ministry of Health, Brazil
Rio de Janeiro, 22240-006
About this study
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.
Read the 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
- Being tested
- skin laser speckle contrast imaging and video-capillaroscopy
- Keywords
- endothelial function, microvascular, laser speckle contrast imaging, capillaroscopy, skin
- Medical subject headings
- Chagas Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin laser speckle contrast imaging and video-capillaroscopyDiagnostic test
Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment
| Study group | Role | What they receive |
|---|---|---|
| patients presenting with Chagas cardiomyopathy | Evaluation of systemic microvascular reactivity using laser speckle contrast imaging Evaluation of skin capillary density using video-capillaroscopy Receives: Diagnostic Test: skin laser speckle contrast imaging and video-capillaroscopy | |
| control group | Evaluation of systemic microvascular reactivity using laser speckle contrast imaging Evaluation of skin capillary density using video-capillaroscopy Receives: Diagnostic Test: skin laser speckle contrast imaging and video-capillaroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelium-dependent skin microvascular function
systemic microvascular vasodilation induced by endothelium-dependent agents
Measured: 2 hours
Secondary outcomes (1)
Endothelium-dependent skin capillary density
capillary opening induced by post-occlusive reactive hyperemia
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start20 Aug 2018
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chagas CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524768
- Sponsor's protocol ID
- CHAGASKASALTIBIRIÇÁ
- Status last verified
- Aug 2020
- First submitted
- 21 Apr 2018
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.
- ClinicalTrials.gov ID
- NCT03524768
- Acronym / sponsor ID
- CHAGASKASALTIBIRIÇÁ
- Conditions
- Chagas Cardiomyopathy
- Keywords
- endothelial function, microvascular, laser speckle contrast imaging, capillaroscopy, skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients presenting with Chagas cardiomyopathy | – | Diagnostic Test: skin laser speckle contrast imaging and video-capillaroscopyEvaluation of systemic microvascular reactivity using laser speckle contrast imaging Evaluation of skin capillary density using video-capillaroscopy |
| control group | – | Diagnostic Test: skin laser speckle contrast imaging and video-capillaroscopyEvaluation of systemic microvascular reactivity using laser speckle contrast imaging Evaluation of skin capillary density using video-capillaroscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients presenting with Chagas cardiomyopathy
Key exclusion criteria (1 listed)
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin laser speckle contrast imaging and video-capillaroscopyEvaluation of endothelial-dependent microvascular reactivity and capillary recruitment | Diagnostic test | control group, patients presenting with Chagas cardiomyopathy |
Primary outcome
Endothelium-dependent skin microvascular function
Time frame: 2 hours
systemic microvascular vasodilation induced by endothelium-dependent agents
1 secondary outcome
Endothelium-dependent skin capillary density
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Chagas Cardiomyopathy
Recruiting
Cardiac Contractility Modulation in Chagas Heart Disease
Chagas Cardiomyopathy, Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chagas Cardiomyopathy, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelium-dependent skin microvascular function (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.