Atorvastatin on Inflammation and Cardiac Function in Chronic Chagas Disease
Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
Chagas Disease, caused by the parasite Trypanosoma cruzi afflicts 7 million people in Latin
America, and due to migration, abroad. The diagnosis lies in clinical suspicion and serologic
detection of antibodies. Cardiac evaluation is essential because complications, including
heart failure and arrhythmias, are the main causes of disability and death. Heart involvement
is explained by a parasite-dependent, immune-mediated myocardial and microvascular injuries.
Current treatment includes the administration of nifurtimox or benznidazole, although in the
chronic phase their efficacy is low and may induce severe adverse events, forcing the
suspension of the therapy. Therefore, finding innovative approaches to improve the efficacy
of the current antichagasic drugs by modifying the inflammatory response would render the
current treatment more effective.
Pre-clinical evidence supports the idea that the cholesterol-lowering statin drugs, such as
atorvastatin, may contribute to decrease cardiac inflammation, reduce endothelial activation,
and improve cardiac function. Atorvastatin therapeutic and safety profiles are well known, as
is its mechanism of action, shared by the other members of the statin class.
This trial aims at evaluating whether atorvastatin, in combination with antichagasic therapy,
is safe and more efficacious in reducing general inflammation than an antiparasitic therapy
alone, by improving endothelial and cardiac functions.
This proof-of-concept trial will be double-blinded, randomized, and multicentered with a
phase II design. To achieve this aim, it will be evaluated the efficacy of the combination of
atorvastatin and antichagasic therapy (nifurtimox or benznidazole) to reduce inflammatory
cytokine plasma levels, soluble endothelial cell adhesion molecules, and confirm the
improvement of the cardiac function by electrocardiogram and two-dimensional echocardiogram.
The trial will set the safety and tolerability of the combination of atorvastatin with
antichagasic therapy by monitoring the incidence of adverse events and discontinuation of the
therapy.
This trial will be conducted with a sample size of 300 adult patients in four hospitals
located in Santiago and Valparaiso, Chile.