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

NCT ID: NCT02099214

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-05

Study Completion Date

2017-10-18

Brief Summary

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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

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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

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Myocardial Iron Overload HFE-Associated Hereditary Hemochromatosis

Keywords

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myocardial iron overload HFE-Associated Hereditary Hemochromatosis 3 Tesla MRI cardiological strategy in haemochromatosis congestive heart failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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 :

* 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.

Group Type EXPERIMENTAL

3Tesla cardiac MRI

Intervention Type DEVICE

Electrocardiogram (EKG)

Intervention Type DEVICE

Iron and cardiac markers

Intervention Type BIOLOGICAL

Serum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNP

Pregnancy test

Intervention Type BIOLOGICAL

Beta-hCG

Echocardiography at rest

Intervention Type DEVICE

Transthoracic echocardiograph

3Tesla abdominal MRI

Intervention Type DEVICE

Healthy volunteers

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.

Group Type EXPERIMENTAL

3Tesla cardiac MRI

Intervention Type DEVICE

Echocardiography at rest

Intervention Type DEVICE

Transthoracic echocardiograph

Urinary pregnancy test

Intervention Type BIOLOGICAL

Interventions

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3Tesla cardiac MRI

Intervention Type DEVICE

Electrocardiogram (EKG)

Intervention Type DEVICE

Iron and cardiac markers

Serum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNP

Intervention Type BIOLOGICAL

Pregnancy test

Beta-hCG

Intervention Type BIOLOGICAL

Echocardiography at rest

Transthoracic echocardiograph

Intervention Type DEVICE

Urinary pregnancy test

Intervention Type BIOLOGICAL

3Tesla abdominal MRI

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients :

* Adults older than 18 ;
* Newly diagnosed with HFE hereditary haemochromatosis by genetic testing (homozygous for the C283Y mutation on HFE gene);
* Treatment-naive;
* Showing a ferritin level higher than 200µg/l for women and higher than 300µg/L for men;
* Affiliated to French Social Security;
* Having given a written informed consent.

Healthy volunteers:

* Adults older than 18;
* Presenting all the following criterions:

* Normal cardiovascular physical examination: no signs of cardiac insufficiency, no pathological cardiac murmur, normal EKG (regular sinus rhythm, no high degree AV nor ventricular blocks, no rhythm anomaly),
* Body Mass Index \<27 kg/m²,
* Normal routine blood biology (blood count, MCV, serum iron, ferritin, transferrin saturation);
* Affiliated to French Social Security;
* Having given a written informed consent.

Exclusion Criteria

Patients :

MRI-related criterions :

* Cardiac pacemaker or implanted defibrillator ;
* Non MRI-compatible prosthetic cardiac valve;
* Non MRI-compatible clips/stents/coils/etc.;
* Cochlear implant;
* Peripheral or neuronal stimulator;
* Intra-ocular or brain metallic foreign bodies , foreign body in the eyes' vicinity, shrapnel or firearm wound;
* Less than 4 weeks-old stents, less than 6 weeks-old osteosynthesis materials;
* Claustrophobia;
* Pumps, tattoos, permanent makeup, intrauterine device, patches;
* Non-removable metallic or magnetic material in the vicinity of the analysed field.

Other criterions :

* Haemodynamic instability / Acute respiratory insufficiency / Altered general status / Need for continuous monitoring incompatible wih MRI confines;
* Pregnancy, breast feeding;
* History of blood transfusion or iron supplementation;
* Blood donation in the last 3 months;
* Infection in the 7 days prior to the first visit;
* Stay in altitude (\>1500m) in the past 2 months;
* Adults under legal protective regimen or deprived of liberty.

Healthy volunteers

* Alcohol abuse (\>20g per day for women, \>30g per day for men);
* Active tobacco intoxication or smoking cessation in the 6 last months;
* Personal cardiovascular medical history;
* Cardiovascular functional signs.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erwan DONAL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital - Service de cardiologie et maladies vasculaires

Bruno LAVIOLLE, MD, PhD

Role: STUDY_CHAIR

Rennes University Hospital

Locations

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Rennes University Hospital

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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2013-A01843-42

Identifier Type: -

Identifier Source: org_study_id