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

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ClinicalTrials.gov Identifier: NCT02099214
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Tracking Information
First Submitted Date  ICMJE March 21, 2014
First Posted Date  ICMJE March 28, 2014
Last Update Posted Date October 20, 2017
Actual Study Start Date  ICMJE November 5, 2014
Actual Primary Completion Date October 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
Myocardial T2* values in haemochromatosis compared to healthy volunteers [ Time Frame: Day 1 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
  • Mean T2 values in healthy volunteers and patients with HFE-related haemochromatosis [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
  • Myocardial T2 and T2* values in both groups [ Time Frame: Day 1 ]
  • Liver T2/T2* values [ Time Frame: Day 1 ]
    Correlation between liver T2/T2* and myocardial T2/T2*
  • Pancreas T2/T2* values [ Time Frame: Day 1 ]
    Correlation between pancreas T2/T2* and myocardial T2/T2*
  • Spleen T2/T2* values [ Time Frame: Day 1 ]
    Correlation between spleen T2/T2* and myocardial T2/T2*
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Estimation of Myocardial Iron Overload by 3 Tesla MRI in HFE Hereditary Haemochromatosis
Official Title  ICMJE Estimation of Myocardial Iron Overload by 3 Tesla MRI and Cardiac Functional Consequences in Patients With HFE Hereditary Haemochromatosis. Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Myocardial Iron Overload
  • HFE-Associated Hereditary Hemochromatosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Device: 3Tesla cardiac MRI
    • Device: Electrocardiogram (EKG)
    • Biological: Iron and cardiac markers
    • Biological: Pregnancy test
    • Device: Echocardiography at rest
    • Device: 3Tesla abdominal MRI
  • Experimental: 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.
    Interventions:
    • Device: 3Tesla cardiac MRI
    • Device: Echocardiography at rest
    • Biological: Urinary pregnancy test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2017)
66
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2014)
60
Actual Study Completion Date  ICMJE October 18, 2017
Actual Primary Completion Date October 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02099214
Other Study ID Numbers  ICMJE 2013-A01843-42
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erwan DONAL, MD, PhD Rennes University Hospital - Service de cardiologie et maladies vasculaires
Study Chair: Bruno LAVIOLLE, MD, PhD Rennes University Hospital
PRS Account Rennes University Hospital
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP