HFE-Associated Hereditary Hemochromatosis Clinical Trial
— HEMOCOEUROfficial title:
Estimation of Myocardial Iron Overload by 3 Tesla MRI and Cardiac Functional Consequences in Patients With HFE Hereditary Haemochromatosis. Pilot Study
| Verified date | October 2017 |
| Source | Rennes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | October 18, 2017 |
| Est. primary completion date | October 18, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Rennes University Hospital | Rennes |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Mean T2 values in healthy volunteers and patients with HFE-related haemochromatosis | Comparison of the mean T2 values in healthy volunteers and patients with HFE-related haemochromatosis | Day 1 | |
| Secondary | Echocardiographic parameters of systolic and diastolic functions and myocardial deformation | Day 1 | ||
| Secondary | Myocardial T2 and T2* values in both groups | Day 1 | ||
| Secondary | Liver T2/T2* values | Correlation between liver T2/T2* and myocardial T2/T2* | Day 1 | |
| Secondary | Pancreas T2/T2* values | Correlation between pancreas T2/T2* and myocardial T2/T2* | Day 1 | |
| Secondary | Spleen T2/T2* values | Correlation between spleen T2/T2* and myocardial T2/T2* | Day 1 |