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Iron Overload clinical trials

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NCT ID: NCT02164253 Completed - Iron Overload Clinical Trials

Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients

SAFEFAIRALS
Start date: September 2013
Phase: Phase 2
Study type: Interventional

The FAIR-ALS study is to investigate the safety and efficacy of a scavenger treatment of iron deferiprone, which would reduce the brain iron to limit the development of amyotrophic lateral sclerosis. It has been shown an excess of iron in the central nervous system carrying a sporadic ALS patients. Iron overload associated with a loss of motor neurons may explain the signs of the disease (atrophy). The investigators discuss the hypothesis that reducing excess iron, the investigators can reduce the loss of neurons and thus the progression of signs of the disease.

NCT ID: NCT02155114 Completed - Inflammation Clinical Trials

Iron Homoeostasis in Inflammation

Start date: April 2014
Phase: N/A
Study type: Observational

The purpose of this study is to survey iron storage levels and their prognostic consequences in the context of acute inflammation. The impact of iron substitution in inflammatory states is controversial. We hypothesize that iron substitution may influence outcome in patients in inflammatory states.

NCT ID: NCT02125877 Completed - Clinical trials for Chronic Iron Overload Due to Transfusion-dependant Anemias

Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)

Start date: July 8, 2014
Phase: Phase 2
Study type: Interventional

Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance

NCT ID: NCT02099214 Completed - Clinical trials for Myocardial Iron Overload

Estimation of Myocardial Iron Overload by 3 Tesla MRI in HFE Hereditary Haemochromatosis

HEMOCOEUR
Start date: November 5, 2014
Phase: N/A
Study type: Interventional

Hereditary haemochromatosis (HHC) is a frequent disease in Brittany (5 to 7‰), responsible first for biological disorder in blood iron parameters and minor clinical disorders, before evolving to potential life-threatening consequences such as diabetes, liver cirrhosis and congestive heart failure. The improvement of screening and treatments made those severe affections rare enough not to evaluate myocardial iron overload a systematic part of the starting check-up. Nonetheless this myocardial iron overload might have severe implications on cardiac function on a long term basis. A single trial was conducted on limited number of patients with 1.5 Tesla MRI, which showed a myocardial iron overload (defined by a myocardium T2* value <20ms) in 19% of the subjects. The main objective of this study is to precisely estimate cardiac iron overload in treatment naive patients with newly diagnosed HFE hereditary haemochromatosis with a 3 Tesla MRI, more sensitive than the 1.5 Tesla one, in order to later appreciate its correlation with cardiac morbidity in HHC.

NCT ID: NCT02090699 Completed - Thalassemia Major Clinical Trials

MR Imaging of Diffuse Myocardial Fibrosis in Transfusion-Dependent Anemias

MAFIO
Start date: July 2013
Phase: N/A
Study type: Observational

Cardiac failure is the major cause of death in patients with thalassemia and chronic blood transfusion-related iron overload. The treatment of thalassemia has been revolutionized over the past decade with the implementation of cardiac MRI based assessment of iron overload. This has enabled detection of cardiac iron overload prior to symptomatic heart failure and now allows for timely therapy which has resulted in a substantial decrease in mortality. However, currently implemented MR imaging techniques assess for iron content only and not for iron related diffuse fibrosis which play a role in iron related heart failure. Histopathologic studies indicate that patients with iron overload have diffuse interstitial fibrosis. Quantitative MR techniques have shown that patients with various cardiomyopathies demonstrate diffuse myocardial fibrosis and that these changes correlate with changes in cardiac function. The investigators propose that quantitative cardiac MRI for assessment of diffuse myocardial fibrosis can further improve our ability to detect early damage to the myocardium and prevent morbidity and mortality from cardiac iron overload. Detection of fibrosis in patients with thalassemia may allow for earlier identification of cardiomyopathy when compared to other techniques in clinical use including T2* analysis. Identification of fibrosis could affect patient management as it would allow for tailoring of iron chelation therapy and may lead to better understanding of the disease processes contributing to heart failure and arrhythmia in these patients.

NCT ID: NCT02066012 Recruiting - Clinical trials for Metabolic Syndrome X

MEPHISTO (Macrophage Phenotype In Metabolic Syndrome With Iron Overload)

MEPHISTO
Start date: February 2014
Phase: N/A
Study type: Observational

Dysmetabolic iron overload syndrome (DIOS), is a frequent hepatic iron overload associated with metabolic syndrome. We hypothesize that this mild iron overload can induce a increased macrophagic polarization towards inflammatory types, thereby contributing to cardiovascular risk. Our main objective is to highlight the influence of iron overload on polarization capacity of monocytes into alternative macrophages (called M2). We therefore compare phenotypic markers of monocytes/macrophages between subjects with DIOS, metabolic syndrome without iron overload and lean subjects.

NCT ID: NCT02041299 Terminated - Sickle Cell Disease Clinical Trials

Efficacy and Safety of Ferriprox® in Patients With Sickle Cell Disease or Other Anemias

FIRST
Start date: April 17, 2014
Phase: Phase 4
Study type: Interventional

This research is being done so that we can look at the safety and efficacy of deferiprone in people with sickle cell disease or other anemias. Deferiprone is a drug that removes iron from the body. We will be comparing deferiprone with deferoxamine, another drug that removes iron from the body.

NCT ID: NCT02025543 Enrolling by invitation - Iron Overload Clinical Trials

Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content

Start date: August 12, 2015
Phase:
Study type: Observational

The purpose of this multi-site research is to validate a rapid magnetic resonance based confounder-corrected R-2 mapping method as a quantitative imaging biomarker of liver iron concentrations.

NCT ID: NCT01965171 Completed - Clinical trials for Acute Myeloid Leukemia

Transfusional Iron Overload Among Leukemia Survivors

Start date: October 18, 2013
Phase: N/A
Study type: Observational

Red cell transfusions are an important part of supportive cancer therapy. The iron in the transfused blood may build up in the body since the human body has no way to get rid of extra iron. Iron tends to build up in the liver and the heart muscle. It is unknown if iron build-up is present many years after completing cancer therapy. It is also not known if extra iron causes harm to internal organs. Researchers at St. Jude Children's Research Hospital (SJCRH) want to understand if iron build-up (called "iron overload") exists in survivors of leukemia. They also want to know if iron overload can cause injury to your organs if it is present. Liver iron accumulation has been documented in childhood cancer survivors, however, it is not known if iron associated organ toxicity is contributing to the long-term morbidity that has been well documented among these survivors. This study will investigate the prevalence of iron overload and the association of tissue iron burden with markers of organ dysfunction in leukemia survivors. This study will determine the prevalence of iron overload among long-term leukemia survivors that underwent blood transfusion. This study will use blood and magnetic resonance imaging (MRI) testing to determine iron overload of specified organs. Understanding the prevalence of iron overload could impact surveillance practices in leukemia survivors. PRIMARY OBJECTIVE: - To determine the prevalence of iron overload in the liver [liver iron concentration (LIC) >3mg/g using R2* MRI measurements] and in the heart (T2* <20 ms) among long-term leukemia survivors transfused with ≥50ml/kg of packed red blood cells. SECONDARY OBJECTIVES: - To examine the relationship between hepatic, cardiac, and endocrine dysfunction and transfusionally acquired iron overload as defined by R2* and T2* MRI among survivors of pediatric leukemias. - To investigate the association between serum ferritin, transferrin saturation, non-transferrin-bound iron, and hepcidin measurements with R2* and T2* MRI-defined iron overload.

NCT ID: NCT01927913 Withdrawn - Metabolic Diseases Clinical Trials

Treatment of Iron Overload Requiring Chelation Therapy

Start date: November 20, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this open-label study is to assess liver iron concentration using MRI imaging in subjects with beta-thalassemia when administered with either SPD602 or deferasirox for the treatment of chronic transfusional iron overload.