Estimation of Myocardial Iron Overload by 3 Tesla MRI in HFE Hereditary Haemochromatosis (HEMOCOEUR)
|ClinicalTrials.gov Identifier: NCT02099214|
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : October 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Iron Overload HFE-Associated Hereditary Hemochromatosis||Device: 3Tesla cardiac MRI Device: Electrocardiogram (EKG) Biological: Iron and cardiac markers Biological: Pregnancy test Device: Echocardiography at rest Biological: Urinary pregnancy test Device: 3Tesla abdominal MRI||Not Applicable|
Since the wide use of phlebotomy was implemented the incidence of congestive heart failure in HHC became quite low. As such, the interest towards the initial diagnosis and cardiological follow-up has been lesser. A subclinical myocardial iron overload can nevertheless exist and eventually lead to functional consequences in the medium and long term if neglected, even evolve into heart failure and preserved ejection fraction.
The expected aftermath of this study is :
- The estimation of the frequency of myocardial iron overload measured by 3 Tesla MRI in patient with HFE hereditary haemochromatosis;
- The assessment of its consequences on heart function;
- The appreciation of a cardiological assessment strategy in patients with HFE hereditary haemochromatosis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Estimation of Myocardial Iron Overload by 3 Tesla MRI and Cardiac Functional Consequences in Patients With HFE Hereditary Haemochromatosis. Pilot Study|
|Actual Study Start Date :||November 5, 2014|
|Actual Primary Completion Date :||October 18, 2017|
|Actual Study Completion Date :||October 18, 2017|
U.S. FDA Resources
Experimental: Patients with HFE hereditary haemochromatosis
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 :
Device: 3Tesla cardiac MRI
Device: Electrocardiogram (EKG)
Biological: Iron and cardiac markers
Serum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNPBiological: Pregnancy test
Beta-hCGDevice: Echocardiography at rest
Transthoracic echocardiographDevice: 3Tesla abdominal MRI
Experimental: Healthy volunteers
The healthy volunteers (10 men and 10 women) will undergo :
Device: 3Tesla cardiac MRI
Device: Echocardiography at rest
Transthoracic echocardiographBiological: Urinary pregnancy test
- Myocardial T2* values in haemochromatosis compared to healthy volunteers [ Time Frame: Day 1 ]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.
- Mean T2 values in healthy volunteers and patients with HFE-related haemochromatosis [ Time Frame: Day 1 ]Comparison of the mean T2 values in healthy volunteers and patients with HFE-related haemochromatosis
- Echocardiographic parameters of systolic and diastolic functions and myocardial deformation [ Time Frame: Day 1 ]
- Myocardial T2 and T2* values in both groups [ Time Frame: Day 1 ]
- Liver T2/T2* values [ Time Frame: Day 1 ]Correlation between liver T2/T2* and myocardial T2/T2*
- Pancreas T2/T2* values [ Time Frame: Day 1 ]Correlation between pancreas T2/T2* and myocardial T2/T2*
- Spleen T2/T2* values [ Time Frame: Day 1 ]Correlation between spleen T2/T2* and myocardial T2/T2*
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099214
|Rennes University Hospital|
|Rennes, France, 35000|
|Principal Investigator:||Erwan DONAL, MD, PhD||Rennes University Hospital - Service de cardiologie et maladies vasculaires|
|Study Chair:||Bruno LAVIOLLE, MD, PhD||Rennes University Hospital|