NCT02099214|Completed
Estimation of Myocardial Iron Overload by 3 Tesla MRI in HFE Hereditary Haemochromatosis
HEMOCOEUR
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HEMOCOEUR
Sponsor study identifier
interventional
66
1 country
1
Study Start
November 5, 2014
Actual (reported)Primary Completion
October 18, 2017
Actual (reported)Study Completion
October 18, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 18, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 21, 2014
Actual (reported)March 28, 2014
Actual (reported)November 5, 2014
Actual (reported)October 18, 2017
Actual (reported)October 18, 2017
Actual (reported)Myocardial T2* values in haemochromatosis compared to healthy volunteers
Assessment of the percentage rate of patients presenting a lower T2\* value than the baseline defined by the mean of T2\* values measured in healthy volunteers with a 1 standard deviation margin.
Day 1
Mean T2 values in healthy volunteers and patients with HFE-related haemochromatosis
Day 1
Echocardiographic parameters of systolic and diastolic functions and myocardial deformation
Day 1
Myocardial T2 and T2* values in both groups
Day 1
Liver T2/T2* values
Day 1
Pancreas T2/T2* values
Day 1
The patients (40) will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : * An electrocardiogram * Blood tests : iron and cardiac markers (serum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNP), beta-hCG if needed, serum bank * A 3Tesla cardiac MRI repeated twice (in order to respect the reproducibility criterion) * A 3Tesla abdominal MRI * An echocardiography at rest.
Rennes University Hospital
Rennes, 35000, France
Erwan DONAL, MD, PhD
Rennes University Hospital - Service de cardiologie et maladies vasculaires
Bruno LAVIOLLE, MD, PhD
Rennes University Hospital
66 participants (actual enrollment reported by the registry).
First Submitted
March 21, 2014
First Posted
March 28, 2014
Study Start
November 5, 2014
Actual (reported)Clinical and Cost Effectiveness of Alpha-Stim AID CES
The healthy volunteers (10 men and 10 women) will undergo : * A urinary pregnancy test (if applicable) * A 3Tesla cardiac MRI repeated twice (in order to respect the reproducibility criterion) * An echocardiography at rest.
Serum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNP
Beta-hCG
Transthoracic echocardiograph
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Primary Completion
October 18, 2017
Actual (reported)Study Completion
October 18, 2017
Actual (reported)Last Updated
October 20, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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