NCT01650792

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

11.9 years

First QC Date

July 24, 2012

Last Update Submit

March 2, 2023

Conditions

Chagas Disease With Heart Failure

Keywords

Chagas diseaseHeart failureStrokeDementia

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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

    One week

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

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

Drug: Aspirin

Best medical treatment

NO INTERVENTION

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

Interventions

AspirinDRUG
Aspirin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Professor Edgard Santos

Salvador, Estado de Bahia, 40110060, Brazil

RECRUITING

MeSH Terms

Conditions

Chagas DiseaseHeart FailureStrokeDementia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne DiseasesHeart DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Jamary Oliveira-Filho, MD, PhD

    Associate Professor, Federal University of Bahia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamary Oliveira-Filho, MD, PhD

CONTACT

+557191620954jamaryof@ufba.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 26, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

March 3, 2023

Record last verified: 2023-03

Locations

BR(1)