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

Primary Purpose

Myocardial Iron Overload, HFE-Associated Hereditary Hemochromatosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3Tesla cardiac MRI
Electrocardiogram (EKG)
Iron and cardiac markers
Pregnancy test
Echocardiography at rest
Urinary pregnancy test
3Tesla abdominal MRI
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Iron Overload focused on measuring myocardial iron overload, HFE-Associated Hereditary Hemochromatosis, 3 Tesla MRI, cardiological strategy in haemochromatosis, congestive heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rennes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with HFE hereditary haemochromatosis

Healthy volunteers

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Echocardiographic parameters of systolic and diastolic functions and myocardial deformation
Myocardial T2 and T2* values in both groups
Liver T2/T2* values
Correlation between liver T2/T2* and myocardial T2/T2*
Pancreas T2/T2* values
Correlation between pancreas T2/T2* and myocardial T2/T2*
Spleen T2/T2* values
Correlation between spleen T2/T2* and myocardial T2/T2*

Full Information

First Posted
March 21, 2014
Last Updated
October 18, 2017
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02099214
Brief Title
Estimation of Myocardial Iron Overload by 3 Tesla MRI in HFE Hereditary Haemochromatosis
Acronym
HEMOCOEUR
Official Title
Estimation of Myocardial Iron Overload by 3 Tesla MRI and Cardiac Functional Consequences in Patients With HFE Hereditary Haemochromatosis. Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 5, 2014 (Actual)
Primary Completion Date
October 18, 2017 (Actual)
Study Completion Date
October 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Iron Overload, HFE-Associated Hereditary Hemochromatosis
Keywords
myocardial iron overload, HFE-Associated Hereditary Hemochromatosis, 3 Tesla MRI, cardiological strategy in haemochromatosis, congestive heart failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with HFE hereditary haemochromatosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
3Tesla cardiac MRI
Intervention Type
Device
Intervention Name(s)
Electrocardiogram (EKG)
Intervention Type
Biological
Intervention Name(s)
Iron and cardiac markers
Intervention Description
Serum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNP
Intervention Type
Biological
Intervention Name(s)
Pregnancy test
Intervention Description
Beta-hCG
Intervention Type
Device
Intervention Name(s)
Echocardiography at rest
Intervention Description
Transthoracic echocardiograph
Intervention Type
Biological
Intervention Name(s)
Urinary pregnancy test
Intervention Type
Device
Intervention Name(s)
3Tesla abdominal MRI
Primary Outcome Measure Information:
Title
Myocardial T2* values in haemochromatosis compared to healthy volunteers
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Mean T2 values in healthy volunteers and patients with HFE-related haemochromatosis
Description
Comparison of the mean T2 values in healthy volunteers and patients with HFE-related haemochromatosis
Time Frame
Day 1
Title
Echocardiographic parameters of systolic and diastolic functions and myocardial deformation
Time Frame
Day 1
Title
Myocardial T2 and T2* values in both groups
Time Frame
Day 1
Title
Liver T2/T2* values
Description
Correlation between liver T2/T2* and myocardial T2/T2*
Time Frame
Day 1
Title
Pancreas T2/T2* values
Description
Correlation between pancreas T2/T2* and myocardial T2/T2*
Time Frame
Day 1
Title
Spleen T2/T2* values
Description
Correlation between spleen T2/T2* and myocardial T2/T2*
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erwan DONAL, MD, PhD
Organizational Affiliation
Rennes University Hospital - Service de cardiologie et maladies vasculaires
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno LAVIOLLE, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

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

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