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

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.

Conditions

• Myocardial Iron Overload
• HFE-Associated Hereditary Hemochromatosis

Interventions

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

Sponsors & Collaborators

• Rennes University Hospital

  lead OTHER

Principal Investigators

• Erwan DONAL, MD, PhD · Rennes University Hospital - Service de cardiologie et maladies vasculaires

• Bruno LAVIOLLE, MD, PhD · Rennes University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-11-05

Primary Completion

2017-10-18

Completion

2017-10-18

Countries

• France

Study Locations