View clinical trials related to Chagas Cardiomyopathy.
Filter by:Chagas disease is an endemic problem in Latin America, where millions of people are chronically infected with T. cruzi. Recently, it was assumed to have clinical and epidemiological relevance in several other countries due to migratory and globalizing social factors. CCC occurs in 30-50% of infected individuals, causing considerable morbidity/mortality rates. Heart failure is the most prevalent morbidity. While CRT and drug treatment have been advocated and implemented without much success to improve the clinical condition of patients with CCC, there is no consistent scientific evidence on the role of cardiac contractility modulation (CCM) as a form of adjuvant treatment for heart failure in patients with CCC. The hypothesis of this study is that patients with CCC, advanced heart failure, severe systolic dysfunction, and non-LBB have better clinical and functional responses when undergoing implantation of a CCM device than when undergoing cardiac resynchronization therapy.
Chagas disease is considered by the World Health Organization (WHO) as one of the most neglected tropical diseases in the world, having relevance in many Latin America countries. In addition, it already affects North America, Europe, Asia and Oceania. Some studies suggest that chagasic heart failure has a worse prognosis, with up to 50% shorter survival than other etiologies. The PARADIGM-HF (Prospective Comparison of Angiotensin Receptor Blocker-Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) study showed 20% reduction in mortality comparing sacubitril/valsartan with the standard treatment with ACE (angiotensin converting enzyme) inhibitors. In the scenario of chagasic cardiomyopathy, a post hoc analysis of PARADGIM-HF was reported on 113 patients. Reduced risk of cardiovascular death or hospitalization for HF was noted in the group treated with sacubitril/valsartan. Attention was drawn the study's limitations that included the small number of patients and reduced statistical power. Therefore, the benefit of this new class remains uncertain in heart failure due to Chagas cardiomyopathy. The ANSWER-HF Trial will be a clinical, randomized, single-center, prospective, double-blind, controlled study. It will include 200 consecutive participants with Chagas cardiomyopathy and left ventricular ejection fraction less than 40% randomized independently. The objective of this study is to evaluate the benefit of sacubitril/valsartan compared with enalapril in patients with heart failure due to Chagas cardiomyopathy, with reduced ejection fraction. The primary endpoint of the study is the change of left ventricular ejection fraction determined by transthoracic echocardiography. Secondary endpoints include: assessment of ventricular arrhythmias; evaluation of functional class; assessment of functional capacity; assessment of ventricular remodeling; and evaluation of biomarkers. The patients will be followed for 6 months after treatment start. All patients will be undergone to Doppler Echocardiography, 24-hour Holter, 6-minute walk test, Biochemical and hematological exams and Biomarkers at the baseline and after 6 months.
Ventricular tachycardia (VT) is the main cause of sudden death in patients with structural heart diseases. The use of ICD (implantable cardio-defibrillator) could prevent sudden death, however, the occurrence of repetitive shock decreases significantly the quality of life and could increase the mortality rate. Chagas disease in our environment is the most common heart disease and often associated with the occurrence appropriate ICD therapies. The chronic treatment of VT aims to prevent recurrences with the use of antiarrhythmic drugs and catheter ablation, but in many cases, these treatments are insufficient to control the VT. Cardiac Sympathetic Denervation by bilateral sympathectomy has been described as an alternative treatment of VT refractory to medical treatment and radiofrequency ablation, especially in patients with channelopathies. This treatment could have a role in patients with structural heart disease. The objective of this study is to evaluate the efficacy of the bilateral sympathectomy in the reduction of ventricular tachycardia in patients with Chagas cardiomyopathy. In this pilot study, the investigators will select 45 patients with Chagas cardiomyopathy with ICD who presented at least four ICD therapies in the prior six months. These patients will be randomly assigned to three groups, 15 patients in medical therapy group, 15 in catheter ablation and 15 in bilateral sympathectomy.
Chagas disease (CD) could be acquired by contact with the vector, transplacentally and by blood transfusion. The duration and clinical presentation of the initial acute phase of the infection may be variable, but the majority of patients are asymptomatic. The acute phase usually lasts a few months and, if untreated, the acute phase goes on to develop a chronic infection. The chronic phase usually continues for the subject's lifetime, and 30% to 40% of patients will progress to the chronic phase with a cardiac, digestive, neurological, or mixed form at 15 to 30 years after the initial infection. Progressive heart failure and sudden death due to ventricular arrhythmias are the main causes of death in patients with chronic Chagas heart disease. Objective: To evaluate cardiac involvement in children after pharmacological treatment for Chagas disease. Methods: Open exploratory study, blind for cardiological evaluation. Population: children treated for Chagas disease with at least 6 years after-treatment parasitological (T.cruzi qPCR), serological (IHA, EIA) and cardiological follow-up. Non-infected subjects were included as a control group for final cardiological evaluation. Treatment: benznidazole or nifurtimox, standard dose, for 60 days. Blood samples were collected at diagnosis, end-of-treatment and every 6-12 months thereafter. Electrocardiogram (ECG) was performed at diagnosis and every year after treatment. In this cohort, 24 hours ECG (Holter) and Speckle-tracking strain echocardiography study were performed at the end of follow-up for this study.
The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients with the cardiac form of Chagas disease, and to search for associations with clinical and laboratory variables.
Purpose: The ATTACH trial, as currently designed, will primarily test whether a treatment with Amiodarone for at least 6 months has a trypanocidal effect among individuals with mild-to-moderate Chronic Chagas Cardiomyopathy. A secondary goal will be to confirm, in this population, a clinical benefit from this treatment (in terms of reducing mortality or cardiac arrhythmic events), and to explore whether a potential trypanocidal effect is associated with a clinical benefit.
BACKGROUND: Chagas Disease (ChD) remains as one of the most neglected diseases in the world, with 8-10 million infected people and only one marginally effective therapeutic. The lack of good biomarkers for active infection or clinical end-points poses a problem for assessing the performance of new drugs or therapeutic interventions. Among the biomarkers, several studies showed that Brain Natriuretic Peptide (NT-ProBNP) is accurate maker of left ventricular systolic and diastolic dysfunction. OBJECTIVE: Our long term goal is to establish The Sao Paulo-Minas Gerais Tropical Medicine Research Center (SaMi-Trop) as a Center of Excellence for Neglected Infectious Disease Research in Brazil. The Specific Aims are to begin that process by focusing on Trypanosoma cruzi infection with the goal of finding an array of biomarkers that correlate with parasite persistence and Chagas cardiac disease status that can be used to infer risk of disease progression and death as well used as markers of cure (parasite eradication) or clinical efficacy (stabilize or reverse cardiac damage) of novel drugs METHOD: The investigators established a prospective cohort of 1,959 patients with chronic Chagas cardiomyopathy (CCC). The study is being conducted in 21 cities of the northern part of Minas Gerais state in Brazil, and includes a follow up of at least two years (baseline and 24 months) . The evaluation included collection of socio-demographic information, social determinants of health, health-related behaviours, comorbidities, medicines in use, history of previous treatment for Chagas Disease (ChD), symptoms, functional class, quality of life, blood sample collection and ECG.
The aim of this investigation is to evaluate the impact of exercise in a cardiac rehabilitation program on functional capacity, clinical markers, quality of life and biomarkers in patients with chronic chagasic cardiomyopathy.
Due to the lack of information in the literature about the role of cardiac rehabilitation on Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac exercise program on functional capacity, cardiac function, respiratory muscle strength, body composition, biomarkers and quality of life among Chagas heart failure patients.
The purpose of this study is to analyze the influence of polymorphisms of the genes CLDN-1 (Claudina-1), LGALS3 (Lectin galactoside-binding soluble 3), SOCS3 (Suppressor of cytokine signaling 3), IL-28B (interleukin-28B), CCL5 (Chemokine C-C ligand 5) in the determination of clinical forms and in the percentage of cardiac fibrosis in patients with Chagas disease.