Chagas DiseaseNCT01842854
Galectin-3 as a Biomarker in Patients With Chagas Disease
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 efficacy of Galectin-3 as a biomarker on the Chagas Disease prognosis. This analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chagas Disease
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to 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 indeterminate form or cardiac form, with and without ventricular dysfunction.
Who cannot join
- Significant valve disease defined as aortic stenosis with a gradient of VE/Ao > 50 mmHg
- Mitral stenosis with a valve area inferior than 1,5 cm2
- Severe or moderate 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 according to the definition of sepsis of the ACCP/SCCM (American College os Chest Physicians/Society of Critical Care Medicine)
Show all 13Show fewer
- Current abusive use of alcohol or illicit drugs (Based on the DSM IV)
- Any other comorbidities that impact patient's survival within the next 2 years
- Liver disease in activity
- Continuous use of steroids as treatment for COPD
- 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
Official title: Validation of Galectin-3 as a Biomarker for Determining Patients Prognosis With Chagas Disease
The purpose of this study is to analyze the efficacy of Galectin-3 as a biomarker on the Chagas Disease prognosis. This analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.
Read the detailed description
Previous studies indicate that activated macrophages secrete Galectin-3, a molecule that is involved in the development of fibrosis and tissue rearrangement in the liver, kidney and the heart. Its plasmatic levels are increased on patients with acute decompensated heart failure. These observations suggest that measuring levels of Galectin-3 in patients with cardiac diseases can be useful to determine their prognosis. To investigate the role of this new biomarker in Chagas Disease, we will study a Chagas Disease population (including patients with the indeterminate and cardiac form of the disease). The assessment of the prognostic value of Galectin-3 will be done through the comparison between its plasmatic levels and each patients's clinical evaluation, disease severity, inflammatory biomarkers and cardiac function tests.
The patients included in the study must at first sign the written consent. They shall be accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael - Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests, including:
- Collection of Blood samples for biochemical analysis;
- Electrocardiogram;
- Holter Electrocardiogram;
- Echocardiogram;
- Treadmill Test;
- X-Ray Imaging;
- Magnetic Resonance Imaging;
- Evaluation of the quality of life through the application of questionnaires (SF 36 and the Minnesota Living With Heart Failure Questionnaire).
- Conditions
- Chagas Disease
- Keywords
- Galectin-3, Chagas disease, 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Chagas disease diagnosis | Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of plasmatic levels of Galectin-3 with the percentage of heart fibrosis
Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging
Measured: One year
Secondary outcomes (4)
Correlation of plasmatic levels of Galectin-3 with the functional capacity of the heart
Mensuration of the functional capacity with treadmill test
Measured: One year
Correlation of plasmatic levels of Galectin-3 with the serum levels of Pro-BNP.
Measured: One year
Correlation of plasmatic levels of Galectin-3 with the serum levels of TNF-alpha
Measured: One year
Correlation of plasmatic levels of Galectin-3 with the serum levels of IFN-gamma.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 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 Botelho Pereira Soares, PhD, Principal investigator, Hospital São RafaelRicardo Ribeiro dos Santos, MD, PhD, Study director, Hospital São RafaelTiciana Ferreira Larocca, MD, MSC, Study chair, Hospital São RafaelMárcia Maria Noya Rabelo, MD, MSC, Study chair, Hospital São RafaelLuís Cláudio Lemos Correia, MD, PhD, Study chair, Hospital São RafaelBruno Solano de Freitas Souza, MD, MSC, Study chair, Hospital São RafaelCarolina Thé Macedo, MD, Study chair, Hospital São Rafael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842854
- Sponsor's protocol ID
- CEP-41-10
- Other IDs
- Galectin-Chagas
- Status last verified
- Nov 2017
- First submitted
- 18 Apr 2013
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Noya-Rabelo MM, Larocca TF, Macedo CT, Torreao JA, Souza BS, Vasconcelos JF, Souza LE, Silva AM, Ribeiro Dos Santos R, Correia LC, Soares MB. Evaluation of Galectin-3 as a Novel Biomarker for Chagas Cardiomyopathy. Cardiology. 2017;136(1):33-39. doi: 10.1159/000447529. Epub 2016 Aug 23.
PubMed 27548475
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Galectin-3 as a Biomarker for Determining Patients Prognosis With Chagas Disease
- ClinicalTrials.gov ID
- NCT01842854
- Acronym / sponsor ID
- CEP-41-10
- Conditions
- Chagas Disease
- Keywords
- Galectin-3, Chagas disease, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Sao RafaelUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Apr 2013 (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 efficacy of Galectin-3 as a biomarker on the Chagas Disease prognosis. This analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.
Detailed description
Previous studies indicate that activated macrophages secrete Galectin-3, a molecule that is involved in the development of fibrosis and tissue rearrangement in the liver, kidney and the heart. Its plasmatic levels are increased on patients with acute decompensated heart failure. These observations suggest that measuring levels of Galectin-3 in patients with cardiac diseases can be useful to determine their prognosis. To investigate the role of this new biomarker in Chagas Disease, we will study a Chagas Disease population (including patients with the indeterminate and cardiac form of the disease). The assessment of the prognostic value of Galectin-3 will be done through the comparison between its plasmatic levels and each patients's clinical evaluation, disease severity, inflammatory biomarkers and cardiac function tests.
The patients included in the study must at first sign the written consent. They shall be accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael - Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests, including:
- Collection of Blood samples for biochemical analysis;
- Electrocardiogram;
- Holter Electrocardiogram;
- Echocardiogram;
- Treadmill Test;
- X-Ray Imaging;
- Magnetic Resonance Imaging;
- Evaluation of the quality of life through the application of questionnaires (SF 36 and the Minnesota Living With Heart Failure Questionnaire).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Chagas disease diagnosis | – | –Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction. |
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 indeterminate form or cardiac form, with and without ventricular dysfunction.
Key exclusion criteria (13 listed)
- Significant valve disease defined as aortic stenosis with a gradient of VE/Ao > 50 mmHg
- Mitral stenosis with a valve area inferior than 1,5 cm2
- Severe or moderate 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.
Primary outcome
Correlation of plasmatic levels of Galectin-3 with the percentage of heart fibrosis
Time frame: One year
Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging
4 secondary outcomes
Correlation of plasmatic levels of Galectin-3 with the functional capacity of the heart
Time frame: One year
Correlation of plasmatic levels of Galectin-3 with the serum levels of Pro-BNP.
Time frame: One year
Correlation of plasmatic levels of Galectin-3 with the serum levels of TNF-alpha
Time frame: One year
Correlation of plasmatic levels of Galectin-3 with the serum levels of IFN-gamma.
Time frame: One year
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 28 Nov 2017.
- Derived from this study: PubMed 27548475Noya-Rabelo MM, Larocca TF, Macedo CT, Torreao JA, Souza BS, Vasconcelos JF, Souza LE, Silva AM, Ribeiro Dos Santos R, Correia LC, Soares MB. Evaluation of Galectin-3 as a Novel Biomarker for Chagas Cardiomyopathy. Cardiology. 2017;136(1):33-39. doi: 10.1159/000447529. Epub 2016 Aug 23.
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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 Botelho Pereira Soares, PhD principal investigator
Hospital São Rafael
Ricardo Ribeiro dos Santos, MD, PhD study director
Hospital São Rafael
Ticiana Ferreira Larocca, 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 28 Nov 2017. 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?
Correlation of plasmatic levels of Galectin-3 with the percentage of heart fibrosis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01842854, which also lists 1 linked publication.
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 28 Nov 2017.