Chagas DiseasePhase 2COACHNCT03704181
Colchicine for Patients With Chagas´ Disease( B1 Stage)
A Phase 2 study testing Colchicine 0.5 MG twice day for one year in people with Chagas Disease and Colchicine Resistance, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study evaluate the addition of colchicine in the treatment of patients with Chagas´disease. Forty patients will receive colchicine while twenty patients will receive placebo Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chagas Disease, Colchicine Resistance
- What is being tested?
- Colchicine 0.5 MG twice day for one year
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 5 Jan 2021
- Phase
- Phase 2
- 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
Who may be able to join
- Clinical and serological diagnosis of Chagas´disease ( Stage B1)
- Must be able to swallow tablets
Who cannot join
- myocardial infarction or coronary artery disease,
- diabetes mellitus,
- valvular disease,
- creatinine clearance <30 ml / kg / min
- contraindication to perform cardiac magnetic resonance imaging
- use of angiotensin converting enzyme inhibitors, angiotensin II receptor blockers and aldosterone blockers
- previous use of benzonidazole
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Fabio Fernandes
São Paulo, 05403000
Fabio Fernandes, MD, +55 11 997681946, fabio.fernandes@incor.usp.br
About this study
Official title: Effect of Colchicine on Inflammation and Myocardial Fibrosis Assessed by Magnetic Resonance Imaging in Patients With Chagas' Heart Disease
This study evaluate the addition of colchicine in the treatment of patients with Chagas´disease.
Forty patients will receive colchicine while twenty patients will receive placebo
Read the detailed description
Chagas disease is considered one of the main cause of dilated cardiomyopathy in Latin America. The histopathological characteristics of Chagas' disease are the presence of myocarditis, destruction of heart fibers, and severe myocardial fibrosis. Colchicine had a protective effect on myocardium, indicated by decreased interstitial myocardial fibrosis and attenuated myocardial inflammation. It is an inflammatory cause of cardiomyopathy and myocardial fibrosis is the hallmark of this disease. Colchicine is a drug used in inflammatory diseases, and could also act on myocardial remodeling interfering in the synthesis of collagen
- Conditions
- Chagas Disease, Colchicine Resistance
- Being tested
- Colchicine 0.5 MG twice day for one year, Placebo Oral Tablet
- Keywords
- fibrosis, Inflammation
- Medical subject headings
- Chagas Disease, Fibrosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MG twice day for one yearDrug
Also called placebo oral tablet
placebo twice day for one year
Placebo Oral TabletDrug
placebo twice day for one year
| Study group | Role | What they receive |
|---|---|---|
| colchicine | Experimental | colchicine 0,5 milligram tablet by mouth every 12 hours, for 1 year Receives: Drug: Colchicine 0.5 MG twice day for one year |
| placebo | Active comparator | placebo tablet by mouth every 12 hours, for 1 year
pill manufactured to mimic coclchicine 0,5 mg tablet Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of colchicine on myocardial inflammation assessed by magnetic resonance imaging
myocardial edema quantified in grams or percent of LV mass, myocardial hyperaemia quantified in grams or percent of LV mass
Measured: 1 year
Effect of colchicine on myocardial fibrosis assessed by magnetic resonance imaging
myocardial fibrosis quantified in grams or percent of LV mass
Measured: 1 year
Secondary outcomes (4)
Effect of colchicine on inflammatory markers such as interleukin-1, interleukin-6, interleukin-8, interleukin-10
interleukin-1, interleukin-6, interleukin-8, interleukin-10, ELISA (pg/mL)
Measured: 1 year
Effect of colchicine on inflammatory marker such as TNF-α
TNF-α ELISA (pg/mL)
Measured: 1 year
Effect of colchicine on inflammatory marker such as interferon-gama
Interferon -gama ELISA (pg/mL)
Measured: 1 year
Effect of colchicine on T Cruzi polymerase chain reaction
7500 PCR-Real time System (Life Technologies)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Oct 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion5 Jan 2021 (estimated)
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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Fabio Fernandes, Md, PHD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704181
- Sponsor's protocol ID
- 4436/16/102
- Acronym
- COACH
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2018
- Last updated
- 11 Mar 2019
- 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 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colchicine on Inflammation and Myocardial Fibrosis Assessed by Magnetic Resonance Imaging in Patients With Chagas' Heart Disease
- ClinicalTrials.gov ID
- NCT03704181
- Acronym / sponsor ID
- COACH / 4436/16/102
- Conditions
- Chagas Disease, Colchicine Resistance
- Keywords
- fibrosis, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 5 Jan 2021 (estimated)
- First posted
- 12 Oct 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.
This study evaluate the addition of colchicine in the treatment of patients with Chagas´disease.
Forty patients will receive colchicine while twenty patients will receive placebo
Detailed description
Chagas disease is considered one of the main cause of dilated cardiomyopathy in Latin America. The histopathological characteristics of Chagas' disease are the presence of myocarditis, destruction of heart fibers, and severe myocardial fibrosis. Colchicine had a protective effect on myocardium, indicated by decreased interstitial myocardial fibrosis and attenuated myocardial inflammation. It is an inflammatory cause of cardiomyopathy and myocardial fibrosis is the hallmark of this disease. Colchicine is a drug used in inflammatory diseases, and could also act on myocardial remodeling interfering in the synthesis of collagen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colchicine | Experimental | Drug: Colchicine 0.5 MG twice day for one yearcolchicine 0,5 milligram tablet by mouth every 12 hours, for 1 year |
| placebo | Active comparator | Drug: Placebo Oral Tabletplacebo tablet by mouth every 12 hours, for 1 year pill manufactured to mimic coclchicine 0,5 mg tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical and serological diagnosis of Chagas´disease ( Stage B1)
- Must be able to swallow tablets
Key exclusion criteria (7 listed)
- myocardial infarction or coronary artery disease,
- diabetes mellitus,
- valvular disease,
- creatinine clearance <30 ml / kg / min
- contraindication to perform cardiac magnetic resonance imaging
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 |
|---|---|---|
| Colchicine 0.5 MG twice day for one yearAlso: placebo oral tabletplacebo twice day for one year | Drug | colchicine |
| Placebo Oral Tabletplacebo twice day for one year | Drug | placebo |
Primary outcome
Effect of colchicine on myocardial inflammation assessed by magnetic resonance imaging
Time frame: 1 year
myocardial edema quantified in grams or percent of LV mass, myocardial hyperaemia quantified in grams or percent of LV mass
Effect of colchicine on myocardial fibrosis assessed by magnetic resonance imaging
Time frame: 1 year
myocardial fibrosis quantified in grams or percent of LV mass
4 secondary outcomes
Effect of colchicine on inflammatory markers such as interleukin-1, interleukin-6, interleukin-8, interleukin-10
Time frame: 1 year
Effect of colchicine on inflammatory marker such as TNF-α
Time frame: 1 year
Effect of colchicine on inflammatory marker such as interferon-gama
Time frame: 1 year
Effect of colchicine on T Cruzi polymerase chain reaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Fabio Fernandes, Md, PHD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine 0.5 MG twice day for one year in people with Chagas Disease and Colchicine Resistance, run by University of Sao Paulo General Hospital 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 7 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: status not confirmed, as of the sponsor's last update on 11 Mar 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio Fernandes, MD, PHD (+55 11 2661 5057, fabio.fernandes@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of colchicine on myocardial inflammation assessed by magnetic resonance imaging (time frame: 1 year). The study lists 2 primary outcomes in all. 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 11 Mar 2019.