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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Federal University of Bahia
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Jamary Oliveira-Filho, Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT01650792
First received: July 24, 2012
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Chagas Disease With Heart Failure
Drug: Aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CHADSS: Chagas Disease Scan Study

Resource links provided by NLM:


Further study details as provided by Federal University of Bahia:

Primary Outcome Measures:
  • Brain magnetic resonance imaging lesions [ Time Frame: Baseline cross-sectional data ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 500
Study Start Date: July 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin
Aspirin 300mg per day for 7 days in patients with HITS on transcranial Doppler monitorization
Drug: Aspirin
No Intervention: Best medical treatment
Best medical treatment including drugs for heart failure and hypertension will be given to both groups.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650792

Contacts
Contact: Jamary Oliveira-Filho, MD, PhD +557191620954 jamaryof@ufba.br

Locations
Brazil
Hospital Universitario Professor Edgard Santos Recruiting
Salvador, Bahia, Brazil, 40110060
Principal Investigator: Jamary Oliveira-Filho, MD, PhD         
Sponsors and Collaborators
Federal University of Bahia
Investigators
Principal Investigator: Jamary Oliveira-Filho, MD, PhD Associate Professor, Federal University of Bahia
  More Information

No publications provided

Responsible Party: Jamary Oliveira-Filho, Associate Professor, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT01650792     History of Changes
Other Study ID Numbers: R01NS064905, R01NS064905
Study First Received: July 24, 2012
Last Updated: July 25, 2012
Health Authority: Brazil: CONEP - Brazilian National Ethics Committee
United States: Institutional Review Board

Keywords provided by Federal University of Bahia:
Chagas disease
Heart failure
Stroke
Dementia

Additional relevant MeSH terms:
Heart Failure
Chagas Disease
Heart Diseases
Cardiovascular Diseases
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014