NCT02099214

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

Estimation of Myocardial Iron Overload by 3 Tesla MRI and Cardiac Functional Consequences in Patients With HFE Hereditary Haemochromatosis. Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Myocardial Iron Overload
• HFE-Associated Hereditary Hemochromatosis

Interventions

Type	Name	Description
DEVICE	3Tesla cardiac MRI
DEVICE	Electrocardiogram (EKG)
BIOLOGICAL	Iron and cardiac markers	Serum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNP
BIOLOGICAL	Pregnancy test	Beta-hCG
DEVICE	Echocardiography at rest	Transthoracic echocardiograph
BIOLOGICAL	Urinary pregnancy test
DEVICE	3Tesla abdominal MRI

Timeline

• Start date: 2014-11-05
• Primary completion: 2017-10-18
• Completion: 2017-10-18
• First posted: 2014-03-28
• Last updated: 2017-10-20

Locations

1 site across 1 country: France