Pilot randomized controlled trial of acetylsalicylic acid to reduce cerebral microembolism in Chagas heart failure - Abstract

Sep 29, 2026

Pilot proof-of-principle PROBE trial evaluated whether acetylsalicylic acid (ASA) lowers high-intensity transient signals (HITS) detected by transcranial Doppler in patients with Chagasic heart failure. Chagasic HF and HITS-positive patients were randomized 2:1 to ASA 300 mg for 7 days plus standard therapy versus standard therapy alone. After one week, the control group showed persistent HITS in contrast to none in the ASA group, and ASA reduced HITS proportion and median HITS count without reported adverse events.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages7

Reading Time18 min

AccessFree to download

Abstract

Background

Objective

Methods

Study design and patients

Results

Conclusion

Article published online: 2025-10-27 Original Article 1 Pilot randomized controlled trial of acetylsalicylic acid to reduce cerebral microembolism in Chagas heart failure Renan Carvalho Castello-Branco 1 Cárita Victoria Carvalho de Santana 1 Victor L. P. P. Botelho 1 Paulo R. S. P. deSousa 1 Maria C. P. Nunes2 Karen L. Furie3 Jamary Oliveira-Filho 1 1 Universidade Federal da Bahia, Hospital Universitario Professor Edgard Santos, Pós-Graduação em Ciências da Saúde, Salvador BA, Brazil. 2 Universidade Federal de Minas Gerais, Faculdade de Medicina, Ambulatório de Insuﬁciência Cardíaca, Belo Horizonte MG, Brazil. 3 Brown University, Neurology Service, Providence RI, United States. Arq. Neuro-Psiquiatr. 2025;83(10):s00451812028 . Address for correspondence Jamary Oliveira-Filho (email: [jamary@mail.harvard.edu](jamary@mail.harvard.edu)) Abstract Keywords ► Cardiomyopathies ► Chagas Disease ► Cerebrovascular Disorders Background Chagas disease is an important cause of heart failure (HF) and stroke, affecting over 6 million people. High-intensity transient signals (HITS) are detected on transcranial Doppler (TCD) in patients with Chagas disease, but the effect of antithrombotic treatment on HITS is unknown. Objective To evaluate whether acetylsalicylic acid (ASA) reduces the frequency and number of HITS in patients with Chagasic HF. Methods Proof-of-principle pilot prospective, randomized, open, blinded endpoint (PROBE) clinical trial, in which patients with both Chagas and HITS were randomized 2:1 to ASA 300 mg for 7 days and standard HF treatment or standard HF treatment alone (control group) . The primary outcome was the proportion of HITS after one week, analyzed using the Chi-squared test. Results A total of 373 patients with HF were evaluated, with HITS occurring in 22/190 (12%) Chagasic patients and in 16/183 (8%) non-Chagasic patients (p ¼ 0.531) . Twelve of the 22 (54%) Chagasic patients were randomized to treatment with (n ¼ 8) or without ASA (n ¼ 4) . Two patients in the control group (50%) persisted with HITS after 7 days of treatment, compared to none in the ASA group, p ¼ 0.028. The median number of HITS decreased from 3.5 to 0 with ASA (p ¼ 0.012) and 4.0 to 0.5 in the control group (p ¼ 0.095), with no signiﬁcant between-group difference (p ¼ 0.262) . No adverse events were reported. Conclusion In the present pilot clinical trial, ASA reduced the proportion of HITS inpatients with Chagas disease HF. received March 8, 2025 received in its ﬁnal form June 24, 2025 accepted July 27, 2025 DOI [https://doi.org/](https://doi.org/)[ ](https://doi.org/)10.1055/s-0045-1812028 . ISSN 0004-282X. Editor-in-Chief: Ayrton Roberto Massaro. Associate Editor: Octávio Marques Pontes Neto. © 2025 . The Author(s) . This is an open access article published by Thieme under the terms of the Creative Commons Attribution 4.0 International License, permitting copying and reproduction so long as the original work is given appropriate credit ([https://creativecommons.org/licenses/by/4.0/](https://creativecommons.org/licenses/by/4.0/)) Thieme Revinter Publicações Ltda. , Rua Rego Freitas, 175, loja 1, República, São Paulo, SP, CEP 01220-010, Brazil 2 Microembolism and Chagas disease Castello-Branco et al. INTRODUCTION Chagas disease affects over 6 million people worldwide, mainly in Latin American countries; however, migration patterns have increased the number of infected individuals in Europe, Japan, Australia, Canada, and the United States.1 Victims are often infected as children, and up to a third eventually develop cardiomyopathy for the rest oftheir lives, increasing the risk of sudden death from arrhythmias and cerebral infarction.2,3 The establishment of non-invasive methods to stratify the risk of stroke in patients with Chagas disease is a priority. Additionally, it is important to deﬁne alternative outcomes to test new treatments for stroke prevention in this population. T

FAQs

What question did the pilot trial address?

The trial evaluated whether acetylsalicylic acid (ASA) reduces the frequency and number of high-intensity transient signals (HITS) in patients with Chagasic heart failure.

How were patients treated and monitored in the study?

Patients with both Chagas disease and HITS were randomized 2:1 to ASA 300 mg for 7 days plus standard heart failure treatment or to standard treatment alone; HITS were assessed after one week using transcranial Doppler.

What were the main findings regarding HITS after 7 days?

In the control group, HITS persisted in two patients after 7 days, while none persisted in the ASA group. ASA also decreased the proportion of HITS and reduced the median number of HITS, with no adverse events reported.

Sep 29, 2026

Uploaded by Olivia Brown