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Chagas Disease clinical trials

View clinical trials related to Chagas Disease.

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NCT ID: NCT02625974 Completed - Chagas Disease Clinical Trials

Prospective Study of a Pediatric Nifurtimox Formulation for Chagas' Disease

Start date: January 27, 2016
Phase: Phase 3
Study type: Interventional

The study consists of two parts. Part I (CHICO) was designed to develop a better understanding of the efficacy, safety and pharmacokinetics of nifurtimox in children with a diagnosis of Chagas' disease (Trypanosoma cruzi infection) using pediatric formulations. Part II (CHICO SECURE) was designed at request of the FDA to assess the incidence of sero-negative conversion in children with diagnosis of Chagas' disease treated with nifurtimox.

NCT ID: NCT02606864 Completed - Chagas Disease Clinical Trials

Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients

Start date: December 2015
Phase: Phase 1
Study type: Interventional

This study will evaluate the effect of food on the absorption of the drug as well as safety and tolerability of the novel 30 mg tablet (administered as 120 mg dose) in adults suffering from chronic Chagas' disease when administered after a high-fat / high-calorie test meal (American breakfast) compared to a fasting state. This study is required as part of the clinical development of an age appropriate pediatric oral dosage form for the treatment of Chagas' disease in endemic countries according to the recommendations provided by current international guidelines (EMA Guideline on Clinical Development of Medicinal Products, EMA Note for Guidance on Oral Dosage Forms).

NCT ID: NCT02517632 Completed - Chagas Disease Clinical Trials

Physical Exercise Program in Chronic Chagas Heart Disease

PEACH
Start date: March 2015
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT02516293 Completed - Chagas Disease Clinical Trials

Cardiac Rehabilitation in Chagas Heart Failure

Start date: May 2013
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT02386358 Completed - Chagas Disease Clinical Trials

Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial

TRAENA
Start date: March 1999
Phase: Phase 3
Study type: Interventional

The purpose of this study is: 1. -to determine whether benznidazole (BZN) will be able to modify the natural evolution of chronic Chagas disease in adult patients by means of a randomized, double-blind clinical trial (RCT). Also: 2. -to validate therapeutic efficacy with new methods, such as recombinant antigen F29 of Trypanosoma cruzi visualized by conventional ELISA, in the context of the RCT compared with conventional serology (CS) 3. -to develop the real-time polymerase chain-reaction (RT-PCR) to quantify the parasite load as an early therapeutic effect. 4. to determine the potential of such serological and parasitological methods as predictors of therapeutic effect or failure.

NCT ID: NCT02346123 Completed - Chagas Disease Clinical Trials

Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy

Start date: June 2015
Phase: N/A
Study type: Observational

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.

NCT ID: NCT02327052 Completed - Chagas Disease Clinical Trials

Assessment of Speckle Tracking Strain Predictive Value for Myocardial Fibrosis in Chagas Disease

Start date: January 2011
Phase:
Study type: Observational

One of the most challenging issues of chronic Chagas disease is to provide earlier detection of heart involvement. Two-dimensional speckle tracking (2-D ST) echocardiography, a new imaging modality with useful applications in several cardiac diseases, has been validated for subjects with myocardial infarction against cardiac magnetic resonance (CMR). Here the investigators hypothesize that the longitudinal global strain (LGS) has an incremental value to ejection fraction for predicting myocardial fibrosis in subjects with Chagas disease.

NCT ID: NCT01927224 Completed - Chagas Disease Clinical Trials

Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients

Start date: November 2013
Phase: Phase 1
Study type: Interventional

This study will evaluate the bioequivalence as well as safety and tolerability of a novel 30 mg tablet of nifurtimox compared to the corresponding marketed 120 mg tablet in adult subjects suffering from chronic Chagas' disease when administered after a high-fat / high-calorie test meal. This study is a necessary step for the development of an age appropriate pediatric oral dosage form for the treatment of Chagas' disease in endemic countries according to the recommendations provided by current international guidelines (EMA Guideline on Clinical Development of Medicinal Products, EMA Note for Guidance on Oral Dosage Forms).

NCT ID: NCT01874795 Completed - Heart Failure Clinical Trials

Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure

Start date: March 2012
Phase: N/A
Study type: Interventional

This study will evaluate the applications of ganglionar electrical stimulation in patients with Chagas Disease and Ischemic Heart Failure patients.

NCT ID: NCT01842880 Completed - Chagas Disease Clinical Trials

MicroRNAs as Biomarkers in Patients With Chagas Disease

Start date: January 2011
Phase: N/A
Study type: Observational

The purpose of this study is to analyze the efficacy of MicroRNAs as biomarkers on the Chagas Disease prognosis. This analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.