Chagas DiseaseNCT02346123
Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy
An observational study of Chagas Disease, run by Hospital Sao Rafael at 1 site in Brazil.
Trial summary
The purpose of this study is to analyze the influence of polymorphisms of the genes CLDN-1 (Claudina-1), LGALS3 (Lectin galactoside-binding soluble 3), SOCS3 (Suppressor of cytokine signaling 3), IL-28B (interleukin-28B), CCL5 (Chemokine C-C ligand 5) in the determination of clinical forms and in the percentage of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Gathering of samples of genetic material
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Jun 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary Hospital
Who may be able to join
- Chagas disease diagnosis confirmed by 2 different serologies
- Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction
Who cannot join
- Significant aortic stenosis
- Mitral stenosis with a valve area inferior than 1,5 cm2
- Superior or moderated aortic and/or mitral regurgitation
- Chronic use of immunosuppressive agents
- Dialysis treatment of terminal renal failure
- Fever on the last 48 hours or evidence of systemic infection in activity
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- Current abusive use of alcohol or illicit drugs
- Any other comorbidities that impact patient's survival within the next 2 years
- Liver disease in activity
- Continuous use of steroids as treatment for chronic obstructive pulmonary disease
- Hematologic, neoplastic or bone diseases
- Homeostasis disturbances
- Inflammatory diseases or chronic infectious diseases
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to analyze the influence of polymorphisms of the genes CLDN-1 (Claudina-1), LGALS3 (Lectin galactoside-binding soluble 3), SOCS3 (Suppressor of cytokine signaling 3), IL-28B (interleukin-28B), CCL5 (Chemokine C-C ligand 5) in the determination of clinical forms and in the percentage of cardiac fibrosis in patients with Chagas disease.
Read the detailed description
The Chagas disease, in its chronic phase, can lead to the development of cardiac arrhythmias and dilated cardiomyopathy, which can evolve to heart failure, causing great morbidity and reduction on patient's quality of life. Some patients stay asymptomatic while others develop the cardiac form of the disease (chronic chagasic cardiomyopathy), or other forms, like the digestive (megacolon and megaesophagus) and the mixed form (cardiac and digestive).
The objective of this study is to analyze the association between single nucleotide polymorphisms with the clinical forms and the amount of cardiac fibrosis in patients with Chagas disease.
The polymorphisms will be analyzed by real time PCR (Polymerase Chain Reaction). The genes whose polymorphisms will be analyzed are: galectin-3, SOCS-3, IL-28B, CLDN-1 and CCL5.
The patients shall be accompanied in the specialized outpatient clinics for Chagas disease - Center of Biotechnology and Cell Therapy. They will be submitted to collection of blood samples for biochemical analysis and cardiac magnetic resonance imaging.
- Conditions
- Chagas Disease
- Being tested
- Gathering of samples of genetic material
- Keywords
- Chagas disease, Polymorphisms, Biomarkers
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gathering of samples of genetic materialGenetic
The samples will be obtained from peripheral blood mononuclear cells and the genotyping of the polymorphisms will be done by real time PCR.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Group which contains all the patients of the study. Receives: Genetic: Gathering of samples of genetic material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease
We will evaluate the presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease.
Measured: The outcome measure will be assessed within one month of follow up.
Secondary outcomes (1)
Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosis
We will evaluate the presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosis assessed by magnetic resonance.
Measured: The outcome measure will be assessed within one month of follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chagas DiseaseStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Rafael
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milena Botelho Pereira Soares, Hospital Sao Rafael
- Investigators
- Milena BP Soares, PhD, Principal investigator, Hospital São RafaelRicardo R dos Santos, PhD, Study director, Hospital São RafaelBruno SF Souza, MD, Msc, Study chair, Hospital São RafaelGabriela S Cruz, Msc, Study chair, Hospital São RafaelTiciana F Larocca, MD, Msc, Study chair, Hospital São RafaelMárcia MN Rabelo, MD, Msc, Study chair, Hospital São RafaelLuís CL Correia, MD, PhD, Study chair, Hospital São Rafael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346123
- Sponsor's protocol ID
- CEP-41-11
- Status last verified
- Oct 2015
- First submitted
- 20 Jan 2015
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02346123
- Acronym / sponsor ID
- CEP-41-11
- Conditions
- Chagas Disease
- Keywords
- Chagas disease, Polymorphisms, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospital Sao RafaelUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jan 2015 (estimated)
- 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 purpose of this study is to analyze the influence of polymorphisms of the genes CLDN-1 (Claudina-1), LGALS3 (Lectin galactoside-binding soluble 3), SOCS3 (Suppressor of cytokine signaling 3), IL-28B (interleukin-28B), CCL5 (Chemokine C-C ligand 5) in the determination of clinical forms and in the percentage of cardiac fibrosis in patients with Chagas disease.
Detailed description
The Chagas disease, in its chronic phase, can lead to the development of cardiac arrhythmias and dilated cardiomyopathy, which can evolve to heart failure, causing great morbidity and reduction on patient's quality of life. Some patients stay asymptomatic while others develop the cardiac form of the disease (chronic chagasic cardiomyopathy), or other forms, like the digestive (megacolon and megaesophagus) and the mixed form (cardiac and digestive).
The objective of this study is to analyze the association between single nucleotide polymorphisms with the clinical forms and the amount of cardiac fibrosis in patients with Chagas disease.
The polymorphisms will be analyzed by real time PCR (Polymerase Chain Reaction). The genes whose polymorphisms will be analyzed are: galectin-3, SOCS-3, IL-28B, CLDN-1 and CCL5.
The patients shall be accompanied in the specialized outpatient clinics for Chagas disease - Center of Biotechnology and Cell Therapy. They will be submitted to collection of blood samples for biochemical analysis and cardiac magnetic resonance imaging.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Genetic: Gathering of samples of genetic materialGroup which contains all the patients of the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary Hospital
Key inclusion criteria (2 listed)
- Chagas disease diagnosis confirmed by 2 different serologies
- Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction
Key exclusion criteria (13 listed)
- Significant aortic stenosis
- Mitral stenosis with a valve area inferior than 1,5 cm2
- Superior or moderated aortic and/or mitral regurgitation
- Chronic use of immunosuppressive agents
- Dialysis treatment of terminal renal failure
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 |
|---|---|---|
| Gathering of samples of genetic materialThe samples will be obtained from peripheral blood mononuclear cells and the genotyping of the polymorphisms will be done by real time PCR. | Genetic | Single group |
Primary outcome
Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease
Time frame: The outcome measure will be assessed within one month of follow up.
We will evaluate the presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease.
1 secondary outcome
Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in subjects with and without myocardial fibrosis
Time frame: The outcome measure will be assessed within one month of follow up.
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 12 Oct 2015.
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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.
Milena BP Soares, PhD principal investigator
Hospital São Rafael
Ricardo R dos Santos, PhD study director
Hospital São Rafael
Bruno SF Souza, MD, Msc study chair
Hospital São Rafael
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 Disease, run by Hospital Sao Rafael 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 2 inclusion and 13 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 12 Oct 2015. 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?
Presence of polymorphisms of the genes CLDN-1, LGALS3, SOCS3, IL-28B, CCL5 in the different forms of Chagas disease (time frame: The outcome measure will be assessed within one month of follow up.). 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 12 Oct 2015.