Trial record 10 of 38 for:    hemochromatosis

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT02099214
First received: March 21, 2014
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Myocardial Iron Overload
HFE-Associated Hereditary Hemochromatosis
Device: 3Tesla cardiac MRI
Device: Electrocardiogram (EKG)
Biological: Iron and cardiac markers
Biological: Pregnancy test
Device: Echocardiography at rest
Biological: Urinary pregnancy test
Device: 3Tesla abdominal MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Estimation of Myocardial Iron Overload by 3 Tesla MRI and Cardiac Functional Consequences in Patients With HFE Hereditary Haemochromatosis. Pilot Study

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Myocardial T2* values in haemochromatosis compared to healthy volunteers [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Myocardial T2 and T2* values in both groups [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Liver T2/T2* values [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Correlation between liver T2/T2* and myocardial T2/T2*

  • Pancreas T2/T2* values [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Correlation between pancreas T2/T2* and myocardial T2/T2*

  • Spleen T2/T2* values [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Correlation between spleen T2/T2* and myocardial T2/T2*


Estimated Enrollment: 60
Study Start Date: September 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Device: 3Tesla cardiac MRI Device: Echocardiography at rest
Transthoracic echocardiograph
Biological: Urinary pregnancy test

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099214

Contacts
Contact: Erwan DONAL, MD, PhD +33299289475 ext +33 erwan.donal@chu-rennes.fr

Locations
France
Rennes University Hospital Not yet recruiting
Rennes, France, 35000
Contact: Erwan DONAL, MD, PhD    +33299289475 ext +33    erwan.donal@chu-rennes.fr   
Principal Investigator: Erwan DONAL, MD, PhD         
Sub-Investigator: Yves GANDON, MD, PhD         
Sub-Investigator: Pierre LENTZ, MD         
Sub-Investigator: Jean-Louis JAGUT, MD         
Sub-Investigator: Yves DEUGNIER, MD, PhD         
Sub-Investigator: Fabrice LAINE, MD         
Sub-Investigator: Anita KIANI, MD         
Sub-Investigator: Maxime FOURNET, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Erwan DONAL, MD, PhD Rennes University Hospital - Service de cardiologie et maladies vasculaires
Study Chair: Bruno LAVIOLLE, MD, PhD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02099214     History of Changes
Other Study ID Numbers: 2013-A01843-42
Study First Received: March 21, 2014
Last Updated: July 23, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Rennes University Hospital:
myocardial iron overload
HFE-Associated Hereditary Hemochromatosis
3 Tesla MRI
cardiological strategy in haemochromatosis
congestive heart failure

Additional relevant MeSH terms:
Hemochromatosis
Iron Overload
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014