Chagas DiseaseNCT04090489
Congenital Chagas Disease: Long Term Follow up of Treated Children. Preliminary Report or Cardiological Evaluation in Chagas Disease Treated Children
An observational study of Chagas Disease and Chagas Cardiomyopathy, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
Trial summary
Chagas disease (CD) could be acquired by contact with the vector, transplacentally and by blood transfusion. The duration and clinical presentation of the initial acute phase of the infection may be variable, but the majority of patients are asymptomatic. Read more about this study
- Who is it for?
- Ages 6 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chagas Disease, Chagas Cardiomyopathy
- How many people
- 120 participants
- Where
- 1 siteArgentina
- Study dates
- 22 Jan 2015to 1 Mar 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 6 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: A cohort of CD treated children with at least 6 years post-treatment parasitological (T. cruzi qPCR), serological and cardiological follow-up. Treatment: benznidazole (Bz) or nifurtimox (Nftx), standard dose, for 60 days.
Who may be able to join
- Chagas diseases children treated with benznidazole / or nifurtimox
- Patients with at least 6 years of after-treatment follow-up.
- Diagnosis of Chagas disease: in infants younger than 8 months by direct observation of T.cruzi using parasitological concentration method (microhematocrit test); in infants older than 9 months 2 reactive serological test (ELISA, Indirect Hemagglutination ).
Who cannot join
- Patients with chronic diseases (renal, hepatic, neurological) that at the discretion of the researcher could affect the interpretation of the results.
- Subjects with congenital heart disease.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Buenos Aires, 1425
About this study
Official title: Post Treatment Evaluation of Terapeutic Response Biomarkers. Cardiological Studies in Children Treated for Chagas Disease
Chagas disease (CD) could be acquired by contact with the vector, transplacentally and by blood transfusion. The duration and clinical presentation of the initial acute phase of the infection may be variable, but the majority of patients are asymptomatic. The acute phase usually lasts a few months and, if untreated, the acute phase goes on to develop a chronic infection. The chronic phase usually continues for the subject's lifetime, and 30% to 40% of patients will progress to the chronic phase with a cardiac, digestive, neurological, or mixed form at 15 to 30 years after the initial infection. Progressive heart failure and sudden death due to ventricular arrhythmias are the main causes of death in patients with chronic Chagas heart disease.
Objective: To evaluate cardiac involvement in children after pharmacological treatment for Chagas disease.
Read more
Methods: Open exploratory study, blind for cardiological evaluation. Population: children treated for Chagas disease with at least 6 years after-treatment parasitological (T.cruzi qPCR), serological (IHA, EIA) and cardiological follow-up. Non-infected subjects were included as a control group for final cardiological evaluation.
Treatment: benznidazole or nifurtimox, standard dose, for 60 days. Blood samples were collected at diagnosis, end-of-treatment and every 6-12 months thereafter.
Electrocardiogram (ECG) was performed at diagnosis and every year after treatment.
In this cohort, 24 hours ECG (Holter) and Speckle-tracking strain echocardiography study were performed at the end of follow-up for this study.
- Conditions
- Chagas Disease, Chagas Cardiomyopathy
- Medical subject headings
- Chagas Disease, Chagas Cardiomyopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of CD treatment in preventing the development of cardiac alterations in treated children.
To compare number of patients with pathological cardiac findings, measured by Holter and ECG, in two different groups: patients with treated Chagas disease (either with Nifurtimox or Benznidazole) and healthy (without Chagas disease) patients of the same population (control group).
Measured: 10 years
Secondary outcomes (1)
Post treatment evaluation of treatment response biomarkers
To compare serology titles in patients treated for Chagas disease (either with Nifurtimox or Benznidazole) with PCR titles in the same group of patients and evaluate if PCR can be an early marker of therapeutic response compared to serology.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start22 Jan 2015
- Primary completion1 Nov 2019
- Study completion1 Mar 2020
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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jaime Altcheh, Hospital de Niños R. Gutierrez de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090489
- Sponsor's protocol ID
- Holter Chagas Children
- Status last verified
- Apr 2020
- First submitted
- 10 Sep 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez NL, Moscatelli G, Moroni S, Ballering G, Jurado L, Falk N, Bochoeyer A, Goldsman A, Grippo M, Freilij H, Garcia Bournissen F, Chatelain E, Altcheh J. Long-term cardiology outcomes in children after early treatment for Chagas disease, an observational study. PLoS Negl Trop Dis. 2022 Dec 19;16(12):e0010968. doi: 10.1371/journal.pntd.0010968. eCollection 2022 Dec.
PubMed 36534647
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Treatment Evaluation of Terapeutic Response Biomarkers. Cardiological Studies in Children Treated for Chagas Disease
- ClinicalTrials.gov ID
- NCT04090489
- Acronym / sponsor ID
- Holter Chagas Children
- Conditions
- Chagas Disease, Chagas Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos AiresUniversity, hospital or other
- Study start
- 22 Jan 2015 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 16 Sep 2019 (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.
Chagas disease (CD) could be acquired by contact with the vector, transplacentally and by blood transfusion. The duration and clinical presentation of the initial acute phase of the infection may be variable, but the majority of patients are asymptomatic. The acute phase usually lasts a few months and, if untreated, the acute phase goes on to develop a chronic infection. The chronic phase usually continues for the subject's lifetime, and 30% to 40% of patients will progress to the chronic phase with a cardiac, digestive, neurological, or mixed form at 15 to 30 years after the initial infection. Progressive heart failure and sudden death due to ventricular arrhythmias are the main causes of death in patients with chronic Chagas heart disease.
Objective: To evaluate cardiac involvement in children after pharmacological treatment for Chagas disease.
Methods: Open exploratory study, blind for cardiological evaluation. Population: children treated for Chagas disease with at least 6 years after-treatment parasitological (T.cruzi qPCR), serological (IHA, EIA) and cardiological follow-up. Non-infected subjects were included as a control group for final cardiological evaluation.
Treatment: benznidazole or nifurtimox, standard dose, for 60 days. Blood samples were collected at diagnosis, end-of-treatment and every 6-12 months thereafter.
Electrocardiogram (ECG) was performed at diagnosis and every year after treatment.
In this cohort, 24 hours ECG (Holter) and Speckle-tracking strain echocardiography study were performed at the end of follow-up for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A cohort of CD treated children with at least 6 years post-treatment parasitological (T. cruzi qPCR), serological and cardiological follow-up. Treatment: benznidazole (Bz) or nifurtimox (Nftx), standard dose, for 60 days.
Key inclusion criteria (3 listed)
- Chagas diseases children treated with benznidazole / or nifurtimox
- Patients with at least 6 years of after-treatment follow-up.
- Diagnosis of Chagas disease: in infants younger than 8 months by direct observation of T.cruzi using parasitological concentration method (microhematocrit test); in infants older than 9 months 2 reactive serological test (ELISA, Indirect Hemagglutination ).
Key exclusion criteria (2 listed)
- Patients with chronic diseases (renal, hepatic, neurological) that at the discretion of the researcher could affect the interpretation of the results.
- Subjects with congenital heart disease.
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
To evaluate the efficacy of CD treatment in preventing the development of cardiac alterations in treated children.
Time frame: 10 years
To compare number of patients with pathological cardiac findings, measured by Holter and ECG, in two different groups: patients with treated Chagas disease (either with Nifurtimox or Benznidazole) and healthy (without Chagas disease) patients of the same population (control group).
1 secondary outcome
Post treatment evaluation of treatment response biomarkers
Time frame: 5 years
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 24 Apr 2020.
- Derived from this study: PubMed 36534647Gonzalez NL, Moscatelli G, Moroni S, Ballering G, Jurado L, Falk N, Bochoeyer A, Goldsman A, Grippo M, Freilij H, Garcia Bournissen F, Chatelain E, Altcheh J. Long-term cardiology outcomes in children after early treatment for Chagas disease, an observational study. PLoS Negl Trop Dis. 2022 Dec 19;16(12):e0010968. doi: 10.1371/journal.pntd.0010968. eCollection 2022 Dec.
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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.
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 Disease and Chagas Cardiomyopathy, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
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 3 inclusion and 2 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 24 Apr 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 Argentina. 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?
To evaluate the efficacy of CD treatment in preventing the development of cardiac alterations in treated children. (time frame: 10 years). 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 NCT04090489, 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 24 Apr 2020.