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Clinical Assessment, Neuroimaging and Immunomarkers in Chagas Disease Study (CLINICS) (CLINICS)

Primary Purpose

Chagas Disease With Heart Failure

Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Aspirin
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chagas Disease With Heart Failure focused on measuring Chagas disease, Heart failure, Stroke, Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of heart failure according to Framingham criteria
  • Informed consent
  • Age 18 years or above

Exclusion Criteria:

  • 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)

Sites / Locations

  • Hospital Universitario Professor Edgard SantosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Aspirin

Best medical treatment

Arm Description

Aspirin 300mg per day for 7 days in patients with HITS on transcranial Doppler monitorization

Best medical treatment including drugs for heart failure and hypertension will be given to both groups.

Outcomes

Primary Outcome Measures

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.
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
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

Secondary Outcome Measures

Full Information

First Posted
July 24, 2012
Last Updated
March 2, 2023
Sponsor
Federal University of Bahia
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT01650792
Brief Title
Clinical Assessment, Neuroimaging and Immunomarkers in Chagas Disease Study (CLINICS)
Acronym
CLINICS
Official Title
CHADSS: Chagas Disease Scan Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2012 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Disease With Heart Failure
Keywords
Chagas disease, Heart failure, Stroke, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Aspirin 300mg per day for 7 days in patients with HITS on transcranial Doppler monitorization
Arm Title
Best medical treatment
Arm Type
No Intervention
Arm Description
Best medical treatment including drugs for heart failure and hypertension will be given to both groups.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Primary Outcome Measure Information:
Title
Brain magnetic resonance imaging lesions
Description
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.
Time Frame
Baseline cross-sectional data
Title
Biomarkers
Description
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
Time Frame
Baseline cross-sectional data
Title
Proportion of high intensity transient signals on transcranial Doppler monitorization
Description
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
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of heart failure according to Framingham criteria Informed consent Age 18 years or above Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamary Oliveira-Filho, MD, PhD
Phone
+557191620954
Email
jamaryof@ufba.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamary Oliveira-Filho, MD, PhD
Organizational Affiliation
Associate Professor, Federal University of Bahia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Professor Edgard Santos
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110060
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamary Oliveira-Filho, MD, PhD

12. IPD Sharing Statement

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Clinical Assessment, Neuroimaging and Immunomarkers in Chagas Disease Study (CLINICS)

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