Chagas Disease With Heart FailurePhase 4CLINICSNCT01650792
Clinical Assessment, Neuroimaging and Immunomarkers in Chagas Disease Study (CLINICS)
A Phase 4 study testing Aspirin in people with Chagas Disease With Heart Failure, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
The main purpose of the study is to determine noninvasive markers of brain involvement in Chagas disease. In a subgroup of patients with high intensity transient signals (HITS) on transcranial Doppler monitorization, the investigators aim to determine the efficacy and safety of aspirin in preventing microembolization… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chagas Disease With Heart Failure
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Jun 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of heart failure according to Framingham criteria
- Informed consent
- Age 18 years or above
Who cannot join
- Patients with a history of an untreated malignancy (except local skin cancers)
- Ischemic stroke (determined using the Questionnaire for Verifying Stroke-Free Status (QVSFS)
- Patients on renal dialysis or with end-stage hepatic dysfunction
- Acute infection/inflammation (Temperature > 101.5 F, and/or WBC> 15, 000)
- Inability to obtain informed consent from patient or next of kin
- Anticoagulant use (warfarin or heparin)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Universitario Professor Edgard Santos
Salvador, Estado de Bahia, 40110060
Jamary Oliveira-Filho, MD, PhD
About this study
Official title: CHADSS: Chagas Disease Scan Study
The main purpose of the study is to determine noninvasive markers of brain involvement in Chagas disease. In a subgroup of patients with high intensity transient signals (HITS) on transcranial Doppler monitorization, the investigators aim to determine the efficacy and safety of aspirin in preventing microembolization in patients with no previous history of stroke. Specific aims are listed bellow:
(1) to establish brain magnetic resonance imaging markers of stroke risk in patients with Chagasic heart failure (HF); (2) to determine whether biomarkers can predict stroke risk in patients with Chagasic HF; and (3) to evaluate the efficacy of antiplatelet treatment in decreasing microembolization rate in patients with Chagasic HF.
Read the detailed description
Stroke is an enormous international public health concern, particularly in the developing world where there are limited resources available to provide for an aging population. One of the main contributors to stroke incidence is the highly prevalent Chagas disease, a parasitic infection affecting an estimated 18 million individuals and a major cause of heart failure in Latin America. Chagas disease conveys stroke risk through two established mechanisms: structural cardiac disease and chronic inflammation. Although inflammation is associated with an increased risk of ischemic stroke and poorer outcome, its role has been largely linked to atherogenesis. Chronic inflammation can result in endothelial dysfunction and stimulate the hemostatic system, increasing systemic fibrin production and platelet activation. Brain atrophy has also been associated with chronic inflammation. Adults, young and old, who develop a secondary cardiomyopathy from Chagas are therefore at higher risk of cardioembolism and neurodegeneration. Stroke patients usually survive, but can be left with significant disability affecting their health status, productivity, and quality of life. These factors impact caregivers as well. Thus, the social and economic consequences of stroke are vast. During our R21 planning grant period, we were able to establish a collaborative infrastructure between the research groups in Brazil and the United States and collect preliminary data. We found an association between Chagas disease and stroke that was independent of cardiomyopathy. Cognitive impairment and brain atrophy were also associated with Chagas disease independently of cardiomyopathy. Biomarkers orosomucoid, neprilysin, interleukin-6 (IL-6) and matrix metalloproteinase-9 (MMP-9) were identified as diagnostic and therapeutic targets in Chagas disease. As part of this phase, we will address three specific aims: (1) to establish brain magnetic resonance imaging markers of stroke risk in patients with Chagasic congestive heart failure (CM); (2) to determine whether biomarkers can predict stroke risk in patients with Chagasic CM; and (3) to evaluate the efficacy of antiplatelet treatment in decreasing microembolization rate in patients with Chagasic CM. The long-term goal of this project is to establish non-invasive methods of stroke risk stratification and prediction of stroke outcome in patients with Chagas disease. This work will also facilitate the development of novel anti-trypanosomal, anti-inflammatory, and antithrombotic strategies for stroke prevention and management in Brazil.
- Conditions
- Chagas Disease With Heart Failure
- Being tested
- Aspirin
- Keywords
- Chagas disease, Heart failure, Stroke, Dementia
- Medical subject headings
- Chagas Disease, Heart Failure, Stroke, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Aspirin 300mg per day for 7 days in patients with HITS on transcranial Doppler monitorization Receives: Drug: Aspirin |
| Best medical treatment | No intervention | Best medical treatment including drugs for heart failure and hypertension will be given to both groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain magnetic resonance imaging lesions
Primary hypothesis is that silent brain infarcts, brain atrophy and white matter disease will be more common in patients with Chagas disease heart failure when compared to other etiologies of heart failure.
Measured: Baseline cross-sectional data
Biomarkers
Primary hypothesis is that serum biomarkers orosomucoid, neprilysin, interleukin-6 and matrix metalloproteinase-9 will be increased in Chagas disease heart failure when compared to other etiologies of heart failure
Measured: Baseline cross-sectional data
Proportion of high intensity transient signals on transcranial Doppler monitorization
Primary hypothesis is that the proportion of patients with high intensity transient signals (HITS) on one-hour transcranial Doppler monitorization after one-week treatment with 300mg aspirin and best medical treatment will be less when compared with best medical treatment without aspirin
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chagas Disease With Heart FailureStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Jamary Oliveira-Filho, Federal University of Bahia
- Investigators
- Jamary Oliveira-Filho, MD, PhD, Principal investigator, Associate Professor, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650792
- Sponsor's protocol ID
- R01NS064905
- Other IDs
- R01NS064905
- Acronym
- CLINICS
- Status last verified
- Mar 2023
- First submitted
- 24 Jul 2012
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHADSS: Chagas Disease Scan Study
- ClinicalTrials.gov ID
- NCT01650792
- Acronym / sponsor ID
- CLINICS / R01NS064905
- Conditions
- Chagas Disease With Heart Failure
- Keywords
- Chagas disease, Heart failure, Stroke, Dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jul 2012 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Jul 2012 (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 main purpose of the study is to determine noninvasive markers of brain involvement in Chagas disease. In a subgroup of patients with high intensity transient signals (HITS) on transcranial Doppler monitorization, the investigators aim to determine the efficacy and safety of aspirin in preventing microembolization in patients with no previous history of stroke. Specific aims are listed bellow:
(1) to establish brain magnetic resonance imaging markers of stroke risk in patients with Chagasic heart failure (HF); (2) to determine whether biomarkers can predict stroke risk in patients with Chagasic HF; and (3) to evaluate the efficacy of antiplatelet treatment in decreasing microembolization rate in patients with Chagasic HF.
Detailed description
Stroke is an enormous international public health concern, particularly in the developing world where there are limited resources available to provide for an aging population. One of the main contributors to stroke incidence is the highly prevalent Chagas disease, a parasitic infection affecting an estimated 18 million individuals and a major cause of heart failure in Latin America. Chagas disease conveys stroke risk through two established mechanisms: structural cardiac disease and chronic inflammation. Although inflammation is associated with an increased risk of ischemic stroke and poorer outcome, its role has been largely linked to atherogenesis. Chronic inflammation can result in endothelial dysfunction and stimulate the hemostatic system, increasing systemic fibrin production and platelet activation. Brain atrophy has also been associated with chronic inflammation. Adults, young and old, who develop a secondary cardiomyopathy from Chagas are therefore at higher risk of cardioembolism and neurodegeneration. Stroke patients usually survive, but can be left with significant disability affecting their health status, productivity, and quality of life. These factors impact caregivers as well. Thus, the social and economic consequences of stroke are vast. During our R21 planning grant period, we were able to establish a collaborative infrastructure between the research groups in Brazil and the United States and collect preliminary data. We found an association between Chagas disease and stroke that was independent of cardiomyopathy. Cognitive impairment and brain atrophy were also associated with Chagas disease independently of cardiomyopathy. Biomarkers orosomucoid, neprilysin, interleukin-6 (IL-6) and matrix metalloproteinase-9 (MMP-9) were identified as diagnostic and therapeutic targets in Chagas disease. As part of this phase, we will address three specific aims: (1) to establish brain magnetic resonance imaging markers of stroke risk in patients with Chagasic congestive heart failure (CM); (2) to determine whether biomarkers can predict stroke risk in patients with Chagasic CM; and (3) to evaluate the efficacy of antiplatelet treatment in decreasing microembolization rate in patients with Chagasic CM. The long-term goal of this project is to establish non-invasive methods of stroke risk stratification and prediction of stroke outcome in patients with Chagas disease. This work will also facilitate the development of novel anti-trypanosomal, anti-inflammatory, and antithrombotic strategies for stroke prevention and management in Brazil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: AspirinAspirin 300mg per day for 7 days in patients with HITS on transcranial Doppler monitorization |
| Best medical treatment | No intervention | –Best medical treatment including drugs for heart failure and hypertension will be given to both groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of heart failure according to Framingham criteria
- Informed consent
- Age 18 years or above
Key exclusion criteria (6 listed)
- Patients with a history of an untreated malignancy (except local skin cancers)
- Ischemic stroke (determined using the Questionnaire for Verifying Stroke-Free Status (QVSFS)
- Patients on renal dialysis or with end-stage hepatic dysfunction
- Acute infection/inflammation (Temperature > 101.5 F, and/or WBC> 15, 000)
- Inability to obtain informed consent from patient or next of kin
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 |
|---|---|---|
| Aspirin | Drug | Aspirin |
Primary outcome
Brain magnetic resonance imaging lesions
Time frame: Baseline cross-sectional data
Primary hypothesis is that silent brain infarcts, brain atrophy and white matter disease will be more common in patients with Chagas disease heart failure when compared to other etiologies of heart failure.
Biomarkers
Time frame: Baseline cross-sectional data
Primary hypothesis is that serum biomarkers orosomucoid, neprilysin, interleukin-6 and matrix metalloproteinase-9 will be increased in Chagas disease heart failure when compared to other etiologies of heart failure
Proportion of high intensity transient signals on transcranial Doppler monitorization
Time frame: One week
Primary hypothesis is that the proportion of patients with high intensity transient signals (HITS) on one-hour transcranial Doppler monitorization after one-week treatment with 300mg aspirin and best medical treatment will be less when compared with best medical treatment without aspirin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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.
Jamary Oliveira-Filho, MD, PhD principal investigator
Associate Professor, Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin in people with Chagas Disease With Heart Failure, run by Federal University of Bahia 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 3 inclusion and 6 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 3 Mar 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jamary Oliveira-Filho, MD, PhD (+557191620954, jamaryof@ufba.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain magnetic resonance imaging lesions (time frame: Baseline cross-sectional data). The study lists 3 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 3 Mar 2023.